SkillsPlus International Info

Management Session: What Every Manager Needs to Know - Onsite GMP & QSR Training

2012-03-20T07:50:00.000-07:00

Management Session: What Every Manager Needs to Know - is a live onsite GMP & QSR training class by SkillsPlus International Inc. This is an instructor led course, taught on-site in-house in-plant at the locations of your choice.

Know your stuff and lead with confidence!

This course addresses CGMP and QSR issues directly relevant to the executive leadership and executive teams of manufacturers.

Upon completion of this class, you'll be able to:
1. State the common 483 observations issued by the FDA.
2. List the basic requirements of CGMP or QSRs that require the attention of the leadership team.
3. Identify gaps in compliance.
4. Identify the issues that needs to be rectified.

For more information, visit:
Management Session: What Every Manager Needs to Know - training by SkillsPlus International Inc.

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Florida Certified Designated Representative Exam Prep - No schedule, take it when needed!

2012-03-19T07:50:00.000-07:00

Why wait, when you don't have to?!

Take your training when you need it, and when you have time to take it!

Check out this online exam prep course that fits into your schedule and needs:
FL Designated Representative online CBT exam preparation by SkillsPlus Intl Inc.

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FL Designated Representative online CBT exam preparation by SkillsPlus Intl Inc.

CA Designated Representative online CBT training certification by SkillsPlus Intl Inc.
CA HMDR Exemptee online CBT training certification by SkillsPlus Intl Inc.

SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website
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California Designated Representative Online Training - No schedule, take it when you want!

2012-03-16T07:50:00.000-07:00

Why wait, when you don't have to?!

Take your training when you need it, and when you have time to take it!

Check out this online training course that fits into your schedule and needs:
California Designated Representative Certification Course

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CA Designated Representative online CBT training certification by SkillsPlus Intl Inc.
FL Designated Representative online CBT exam preparation by SkillsPlus Intl Inc.
CA HMDR Exemptee online CBT training certification by SkillsPlus Intl Inc.

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ISO 17025: Calibration Laboratories - Onsite Training Class

2012-03-14T07:50:00.000-07:00

If you need to understand the expectations of a metrology lab from the global perspective, and not just from the US perspective, then you need this course:

ISO 17025: Calibration Laboratories - live on-site training by SkillsPlus International Inc.

In this class, you'll learn the details of ISO 17025 as it relates to calibration laboratories. This class is instructor-led, and taught on-site in-plant, at client locations.

Upon class completion, students will be able to:

Explain the rationale for ISO 17025.
Explain the management requirements from a regulatory perspective.
Explain the technical requirements from a regulatory perspective.

For more information, and to view a list of the topics covered, visit:

ISO 17025: Calibration Laboratories - live on-site training by SkillsPlus International Inc.

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Using Video In The Classroom - Free GMP and QSR Training Tip

2012-03-12T07:50:00.000-07:00

Image via Wikipedia

Using videos and DVDs in the classroom isn't difficult. And they're not intended to be a babysitter while the instructor gets a cup of coffee. Successfully using videos and DVDs in the classroom requires four simple steps, three of which are often forgotten, and a qualified instructor.

Tell the class what they are going to see and why you want them to see it.
Give the class an assignment to perform during and immediately after the video or DVD has ended. The assignment can be as simple as, "During this DVD write down as many things you did not know prior to watching this DVD."
Now it's time to turn on the DVD. See our list of SkillsPlus Intl Inc. movies and interactive CBTs
After the DVD is over, follow up on what the class has learned. Using the round robin technique, chart everybody's responses. As an instructor, elaborate on the class response as appropriate.

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Human Errors: Overcoming the Challenges - Onsite cGMP & QSR training

2012-03-07T07:50:00.000-08:00

Human Errors: Overcoming the Challenges - live on-site cGMP & QSR training by SkillsPlus International Inc.

Humans make errors, AND, more likely, there are processes and systems that are root causes of setting people up to fail.

Purpose:
This class teaches how to overcome human errors as a root cause to deviations.

Objectives: upon class completion, students will be able to . . .
1. State what the CGMPs imply regarding human errors.
2. State the FDA's current thinking about human errors and deviations.
3. Describe the basics of root cause determination.
4. List the possible root causes to human errors.

Topics Covered:

Overview of 483 observations
Psychology of human failures
Investigating human errors
Preventing human errors

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Executive Session: What Leadership Needs to Know - Onsite cGMP & QSR training

2012-03-05T07:50:00.000-08:00

Executive Session: What Leadership Needs to Know - live onsite cGMP & QSR training by SkillsPlus International Inc.

Executives and top leadership teams need to be knowledgeable, in order to lead the troops!

Purpose:
Addresses CGMP and QSR issues directly relevant to the executive leadership and executive teams of manufacturers.

Objectives: upon class completion, leaders will be able to . . .
1. State the common 483 observations issued by the FDA.
2. List the basic requirements of CGMP or QSRs that require the attention of the leadership team.
3. Identify gaps in compliance.
4. Identify the issues that needs to be rectified.

For more information, visit:
Executive Session: What Leadership Needs to Know - live onsite cGMP & QSR training by SkillsPlus International Inc.

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Essentials for Pharmaceutical Manufacturers - Live onsite cGMP training

2012-03-01T07:50:00.000-08:00

Essentials for Pharmaceutical Manufacturers is a SkillsPlus International Inc. course - it's a live onsite cGMP training class taught on-site, in-house, at client plant locations.

It's the perfect introductory class for employees new to the pharma-biotech industry, and also serves as a wonderful refresher course for staff needing continuing education.

By the end of this engaging interactive class, students will be able to:
1. State the historical development of CGMP regulations.
2. Explain the role and function of standard operating procedures.
3. Describe the personal role for contamination control.
4. Identify the sources of contamination.
. . . and much more!

For more information, go to:
Essentials for Pharmaceutical Manufacturers is a SkillsPlus International Inc. course

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Essentials for Medical Device Manufacturers - Live onsite QSR training class

2012-02-27T07:50:00.000-08:00

In this original or refresher training, experience fun learning the regulations.

Essentials for Medical Device Manufacturers by SkillsPlus International Inc. is an instructor-led training class, taught on-site in-house at client plant locations. This is useful as a new employee basics course, and can be used as a refresher course.

Purpose:
This class teaches employees how to identify the essential elements of QSR for beginning work in the medical device industry.

Objectives:
Upon class completion, students will be able to . . .
1. State the historical development of QSR regulations.
2. Explain the role and function of standard operating procedures.
3. Describe the personal role for contamination control.
4. Identify the sources of contamination.
5. List the common QSR documentation practices.
6. Explain material controls.
7. State the common practices of production and process controls.
8. Explain the importance of an adequate, appropriate, and sufficient building design.
9. State the requirements of equipment design and construction.
10. List the requirements for building, and equipment cleaning and maintenance.
11. Explain the role of the quality management system.
12. Explain the role of the laboratory.

Topics:

Heard on the street
Past, present, and future
Legal issues
Personnel responsibilities
Standard operating procedures
Contamination
Personal hygiene
Cleaning
Documentation
Materials
Process control
Buildings and facilities
Equipment
Validation
Calibration
Laboratory
Quality management system

For more information about this class:
Essentials for Medical Device Manufacturers by SkillsPlus International Inc

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Additional Keywords: biotech, cGMP, class, compliance, course, device,energizing, engaging, exciting, FDA, GMP, instructor, interactive, international, manufacturer, medical, QSR, seminar, SkillsPlus,trainer,training

Deviation Investigation Reports - Live onsite cGMP & QSR training class

2012-02-21T07:50:00.000-08:00

Deviation Investigation Reports is a live on-site cGMP & QSR training class taught by SkillsPlus International Inc.

This class is instructor-led, and is taught at client manufacturing plant locations.

Purpose:
This class teaches students how to use the data collected in an investigation to write a report and answer management and FDA questions. Students learn how to summarize the important points of the investigation that support the root causes.

Objectives:
Upon class completion, students will be able to:

Increase investigation report suitability for FDA review.
Decrease the number reports returned by internal reviewers.
Write supported deviation statements.
Provide a detailed background statement to include related information, investigations, affected materials and references.
Document deviation investigation findings.
State the root cause with supporting facts.
Generate supported, plausible, and defensible corrective actions.
Develop effectiveness measures for the corrective actions.
Generate realistic preventive actions.
Develop effectiveness measures for the preventive actions.
Develop a follow up plan for corrective and preventive actions.
Write accurate executive summary statements.

Class Topics:

Incident description
Investigations and affected materials
Deviation investigations
Corrections (path forward)
Corrective actions
Preventive actions
Background information

For more information, visit:

Deviation Investigation Reports is a live on-site cGMP & QSR training class taught by SkillsPlus International Inc.

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Additional Keywords: cGMP, GMP, QSR, live,onsite,on-site,in-plant,plant,instructor-led,training,class, course, FDA, deviation, investigation,reports, CAPA, SkillsPlus

Root Cause Analysis for Better Investigations - Live onsite cGMP & QSR training class

2012-02-18T07:40:00.000-08:00

Root Cause Analysis for Better Investigations - onsite cGMP & QSR training by SkillsPlus International Inc.

Learn how to conduct better investigations and address CAPA regulatory requirements. This is an instructor-led live training class, taught on-site at client locations.

Purpose of this live class:

Teaches students how to conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries.

Objectives for this onsite training:
Upon course completion, students will be able to . . .

Use tools and techniques to effectively identify the deviation statement.
Identify the root cause of the deviation.
Generate and objectively select the best corrective and preventive actions.
Assess the risk of implementing the corrective action and preventive action.
Develop a contingency plan to preventive action implementation.
Create corrective actions and preventive action metrics.

Course topics include:

Deviation statement
Deviation investigation
Root cause analysis
Corrective actions
Preventive actions
Risk analysis
Metrics

For more course information:
Root Cause Analysis for Better Investigations - onsite cGMP & QSR training by SkillsPlus International Inc.

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Additional Keywords: biotech, cGMP, class, compliance, course, device, drug, FDA, GMP, instructor, interactive, International, manufacturer, medical, pharmaceutical, QSR, seminar, SkillsPlus, training

Creating CGMP and QSR Responsibility and Accountability - Onsite Training Class

2012-02-14T07:50:00.000-08:00

Live onsite GMP & QSR training class:
Creating CGMP and QSR Responsibility and Accountability - training by SkillsPlus International Inc.

This is instructor-led, and taught on-site at client locations.

Giving feedback can be challenging, and doing so in a regulated industry makes it even more interesting. Don't get stymied, learn how to do it easily and effectively.

Purpose of this class:
To raise the standard of CGMP and QSR compliance throughout the organization, and to provide strong and positive coaching techniques.

Objectives:
Upon completion of this class, studenst will be able to:

Review the CGMP/QSR Regulations.
Set climate for a compliance discussion.
Create a compliance message.
Provide behavioral feed back.
Create responsibility for CGMPs and performance.
Establish an atmosphere of accountability.
Hold non-threatening discussions with employees as a part of a corrective action plan.

Topics include:

Direct reports
Communication skills for supervisors and leaders
Motivation
Goals
Delegation
The compliance message

Get more details about this class:

Creating CGMP and QSR Responsibility and Accountability - training by SkillsPlus International Inc.

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Additional Keywords: biotech, cGMP, class, compliance, device, drug, FDA, GMP, instructor, manufacturer, medical, pharmaceutical, QSR, SkillsPlus, training,

Follow SkillsPlus Intl Inc via Constant Contact

2012-02-13T07:50:00.000-08:00

After reading this, you should sign-up to receive our free electronic mailings.

SkillsPlus International Inc. offers our current and prospective clients a variety of ways to learn about our cGMP & QSR compliance training products and services. One way is to tap into a collection of quick links posted on the top right of the SkillsPlus International Info Blog. Another obvious way, is to go directly to the SkillsPlus International Inc. website.

Sometimes, there are too many options. We're also aware that some folks prefer to receive 'pushed' information.

If you'd like to receive our free emailed promotional material and announcements, then just follow this link to sign-up via Constant Contact: SkillsPlus via Constant Contact - Sign-up for Announcements

References:
About Constant Contact

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Additional Keywords: affordable, based, biotech, CA, CBT, CDPH, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, cosmetics, course, DBPR, DDC, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, energizing, engaging, etraining, e-training, exam, examination, exemptee, exciting, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, movie, online, Pearson VUE,pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, social, trainer, training, video, WBT
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Faster Product Release Through Efficient Batch Record Review - Onsite cGMP & QSR Training Class

2012-02-07T07:11:00.000-08:00

Faster Product Release Through Efficient Batch Record Review - Live onsite cGMP & QSR training by SkillsPlus International Inc.

This is a live on-site class. It is instructor-led and taught at the client location of your choice.

Purpose:
This live on-site GMP & QSR training class teaches students how to competently review batch records to identify errors and issues.

Objectives:
Upon course completion, students will be able to:
1. State the source of batch record requirements for both US and EU
2. Distinguish between the production and QA batch record review
3. List best practices in Batch Record Review
4. Demonstrate at least 5 different batch record review activities.

Topics include:

Regulation review
US & EU Requirements and Regulatory Expectations
Best Practices
BPR Regulations Background
BPR Audit Items: Skills Practice
Trending

For more information, visit:

Faster Product Release Through Efficient Batch Record Review - Live onsite cGMP & QSR training by SkillsPlus International Inc.

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Additional Keywords: biotech, cGMP, class, compliance, device, DME, drug, energizing, engaging, exciting, FDA, GMP, instructor, interactive, manufacturer, medical, ,pharmaceutical, QSR, SkillsPlus, trainer, training,

Auditing: Internal and External Customers and Suppliers - Onsite GMP & QSR Class

2012-01-31T07:50:00.000-08:00

Auditing: Internal and External Customers and Suppliers - is a live on-site cGMP and QSR class by SkillsPlus International Inc. This training is delivered as an in-house class taught at the client's location.

Purpose:
This class teaches students how to:

apply an auditing model that applies to a wide-variety of situations
qualify suppliers, to assure that they meet your specifications and appropriate GMPs

Objectives:
Upon class completion, students will be able to:

State the regulatory requirements for audits.
Identify common reactions to the audit process.
Manage adverse reactions to audits.
Plan an efficient and thorough audit.
Apply the Quality System inspection approach for audit planning.
Review relevant regulations applicable to the audit area.
Gather evidence of compliance/noncompliance.
Report results to affect change and build relationships.
Manage the corrective action and preventive action process

Topics covered in class include:

Managing audits
Pre-audit questionnaire
Audit focus
Gathering evidence
Ratings
Auditing report

Learn more about this onsite class:

Auditing: Internal and External Customers and Suppliers: SkillsPlus International Inc.

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Additional Keywords: affordable, biotech, cGMP, class, compliance, course, device, drug,energizing, engaging, exciting, FDA, GMP, interactive, International, manufacturer, medical,pharmaceutical, QSR, SkillsPlus, training

cGMP/QSR Trainer Certification - Public Seminar - Oct 22-26, 2012

2012-01-30T07:50:00.000-08:00

cGMP/QSR Trainer Certification Program
(offered as a public seminar Oct 22-26, 2012 in San Francisco, CA)

This is a five-day class where participants experience many different ways to teach CGMPs and QSRs. Then learn what your instructor is thinking about during sessions so that you can repeat that training approach in your organization. Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also.

For more details, check-out the brochure: CGMP/QSR Trainer Certification Program (PDF)

To register for the class: Register for the CGMP/QSR Trainer Certification Program

Public Seminar Schedule and Course Description: SkillPlus International Inc.

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Root Cause Analysis for Better Deviation Investigations - Live onsite GMP & QSR training

2012-01-25T07:50:00.000-08:00

Don't miss this popular course. This cGMP & QSR training class can be taught at the location of your choice, as a client on-site in-house training.

Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.:

"Purpose:
To conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries.

Objectives
1. Use tools and techniques to effectively identify the deviation statement.
2. Identify the root cause of the deviation.
3. Generate and objectively select the best corrective and preventive actions.
4. Assess the risk of implementing the corrective action and preventive action.
5. Develop a contingency plan to preventive action implementation.
6. Create corrective actions and preventive action metrics.

About the Class
1. This class uses current deviations to practice the techniques taught.
2. The optional final exam is approximately 25 questions.
3. Each student receives a student guide containing a representation of the program's
slides and graphics with space provided for note taking.
4. This class can accommodate up to 25 people.
5. Duration: 8 hours."

'via Blog this'

For more information:
Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.

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Additional Keywords: affordable, cGMP, class, compliance, device, drug,energizing, engaging, exciting, FDA, GMP, interactive, manufacturer, medical, pharmaceutical, QSR, SkillsPlus, training

Live Onsite QSR Training - Olympics for Medical Device Manufacturers

2012-01-24T07:50:00.000-08:00

Olympics for Medical Device Manufacturers - onsite QSR training by SkillsPlus International Inc. is an exciting, energizing, and engaging on-site class that can be held at a client in-house location.

This challenging class takes QSRs to a deeper level of understanding through a series of challenging activities.

Upon class completion, students will be able to:

List the hottest issues in QSR compliance.
Locate items of interest in 21CFR820.
Explain the 21CFR211 rationale for specific 483 observations.
Demonstrate knowledge of common CGMP practices and details.
State the consequences of not following QSR.

For more information:

Olympics for Medical Device Manufacturers - onsite QSR training by SkillsPlus International Inc.

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Additional Keywords: affordable, class, compliance, course, device, energizing, engaging, exciting, FDA, interactive, manufacturer, medical, QSR, SkillsPlus,

Live Onsite GMP Training - Olympics for Pharma & Biotech Manufacturers

2012-01-23T07:50:00.000-08:00

Exciting, energizing, engaging, live client site class held at your location.
Olympics for Pharmaceutical and Biotech Manufacturers - On-site cGMP Training by SkillsPlus International Inc.

This class takes CGMPs to a deeper level of understanding through a series of challenging activities.

Upon class completion, students will be able to:

List the hottest issues in CGMP compliance.
Locate items of interest in 21CFR211.
Explain the 21CFR211 rationale for specific 483 observations.
Demonstrate knowledge of common CGMP practices and details.
State the consequences of not following CGMPs.

For more information:

Olympics for Pharmaceutical and Biotech Manufacturers - On-site cGMP Training by SkillsPlus International Inc.

Additional Keywords: affordable, biotech, cGMP, class, compliance, computer, computer-based training, cosmetics, course,drug,energizing, engaging,exciting, FDA, GMP, instructor, interactive, manufacturer,pharmaceutical,SkillsPlus, training

Live Onsite QSR Training - Essentials for Medical Device Manufacturers

2012-01-18T07:50:00.000-08:00

Here's one of our popular onsite QSR training classes:
Essentials for Medical Device Manufacturers by SkillsPlus International Inc.

This live class can be taught at the client site location of your choice.

This class teaches employees how to identify the essential elements of QSR for beginning work in the medical device industry.

Upon completion of this class, students will be able to:

State the historical development of QSR regulations.
Explain the role and function of standard operating procedures.
Describe the personal role for contamination control.
Identify the sources of contamination.
List the common QSR documentation practices.
Explain material controls.
State the common practices of production and process controls.
Explain the importance of an adequate, appropriate, and sufficient building design.
State the requirements of equipment design and construction.
List the requirements for building, and equipment cleaning and maintenance.
Explain the role of the quality management system.
Explain the role of the laboratory.

Learn more about this class:
Essentials for Medical Device Manufacturers - On-site training by SkillsPlus International Inc.

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Live Onsite GMP Training - Essentials for Pharmaceutical Manufacturers

2012-01-16T07:50:00.000-08:00

Here's one of our popular onsite cGMP training classes:
Essentials for Pharmaceutical Manufacturers - cGMP training by SkillsPlus Intl Inc.

This live class can be taught at the client site location of your choice.

This class teaches employees how to identify the essential elements of CGMP for beginning work in the pharmaceutical and biotech industries.

Upon completion of this class, students will be able to:

State the historical development of CGMP regulations.
Explain the role and function of standard operating procedures.
Describe the personal role for contamination control.
Identify the sources of contamination.
List the common CGMP documentation practices.
Explain material controls.
State the common practices of production and process controls.
Explain the importance of an adequate, appropriate, and sufficient building design.
State the requirements of equipment design and construction.
List the requirements for building, and equipment cleaning and maintenance.
Explain the role of quality assurance.
Explain the role of quality control.

Learn more about this class:
Essentials for Pharmaceutical Manufacturers - cGMP training by SkillsPlus Intl Inc.

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cGMP QSR On Site Classes - The Benefits

2012-01-09T07:50:00.000-08:00

On-site training is the perfect choice for companies that need to train groups of employees.

Onsite Training Benefits:

You get a maximum number of employees trained in new skills in a minimal amount of time on the date, and location of your choice.
You'll be able to deliver the same customized message & course content at the same time, ensuring everybody gets on the same page.
You can ensure knowledge & skills transfer from classroom to workplace.
You can minimize employee time away from the office or production line.

Taking advantage of onsite training classes gives you the optimal balance of facilitation, group exercises, case studies, and practical application exercises. Call our master trainer, Allan Dewes, to arrange your next client site class, (415) 487-3500.

You might also be interested in:
2012 cGMP & QSR compliance training course catalog by SkillsPlus International Inc.

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2012 Onsite cGMP & QSR Compliance Courses by SkillsPlus Intl Inc.

2012-01-04T07:50:00.000-08:00

Happy New Year!

Now that 2012 is here, don't delay your training planning.

We've got an exciting, energizing, and engaging slate of cGMP and QSR training courses and classes to offer you.

Check out our new:
2012 cGMP & QSR compliance training course catalog by SkillsPlus International Inc.

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About Florida Certified Designated Representative (CDR)

2012-01-03T07:50:00.000-08:00

Florida Department of Business and Professional Regulation - Certified Designated Representative:

"Drugs, Devices, and Cosmetics Program - Certified Designated Representative: All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment. Such person must have an active certification from the department (a “certified designated representative” or “CDR”)."

'via Blog this'

Learn about the FL CDR program at the webpage above. It covers:

requirements
application
certification criteria
operational requirements
fees

You might also be interested in:
Florida Designated Representative Study Course: online web training by SkillsPlus International Inc.

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Don't Get Caught Without A California HMDR Exemptee

2011-12-31T10:38:00.000-08:00

Avoid jeopardizing your business.

Don't get caught without a California Department of Public Health (CDPH) Home Medical Device Retailer (HMDR) Exemptee.
It's a wise investment to have more than just one Exemptee, so that you have additional Exemptees for backup and cross-covering.
The cost of training another Exemptee is very reasonable, in contrast to having to close down the business.

Here's a free tip:
One of many minimum qualifications to become a California HMDR Exemptee is work experience. Applicants must have one or more years paid experience. Training must have been supervised by a licensed exemptee, Pharmacist-In-Charge or equivalent. No exceptions!

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2012 cGMP QSR Trainer Certification Course - Public Seminar

2011-12-22T17:37:00.000-08:00

Announcing our 2012 offering in scenic San Francisco:
cGMP/QSR Trainer Certification Program - a 2012 Public Seminar by SkillsPlus International Inc.

This is a life-changing five-day class in which participants experience many different ways to teach CGMPs and QSRs. Learn what your instructor is thinking about during sessions, so that you can repeat that training approach in your organization.

Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also.

Upon course completion, participants will be able to:

Explain the essentials of the CGMP/QSR regulations.
Use the philosophical basis for the rules and interpretation to respond to CGMP/QSR related questions.
Demonstrate techniques to present CGMP/QSR content in memorable ways.
Design and conduct activities that reinforcement learning.
Facilitate discussions and questions like a pro.
Respond to difficult questions.
Deal successfully with difficult students.
Manage class room media.

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Florida Designated Representative - Online Exam Preparation Course

2011-12-14T19:28:00.000-08:00

Florida Designated Representative Exam Preparation Course: SkillsPlus International Inc.:

"Florida requires Designated Representatives working at drug and device wholesalers to be trained in specific Florida Pharmacy Laws. SkillsPlus offers an on line self study course that helps prospective Designated Representatives to prepare for the examination. Simply enroll and follow the links in a confirmation email and you are on your way."

'via Blog this'

Here's a free preview of the course:

You might also be interested in:
Selecting e-Learning that is Pure, Safe, and Effective

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California HMDR Exemptee - Online CBT Training

2011-12-07T07:50:00.000-08:00

SkillsPlus International Inc. is a long running provider of training to home medical device retailers (HMDR) and durable medical equipment (DME) wholesalers. Since 2002, SkillsPlus has provided up-to-date training for their clients. Our website page, California Exemptee HMDR and DME Providers Certification Course by SkillsPlus Intl Inc., provides information specific to the California Exemptee certification course. For those seeking two certifications, this course also meets the requirements for the California Designated Representative. California requires home medical device retailers to retain an on-site Exemptee to conduct their business. The Exemptee must be physically present during all hours of operation. This course is recommended by the Department of Public Health as it meets training requirements for this training.To meet this requirement, we offer a web-based, self-study class and the final exam for this certification. The class is fast, to the point, and has helped thousands of potential California Exemptees get licensed.

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e-Pedigree - CA Board of Pharmacy Mtg 9/7/2011

2011-12-06T16:46:00.000-08:00

Skillsplusinc's Channel - YouTube:

The CA Board of Pharmacy finally posted the minutes to this meeting.

It includes:
Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Drug (PDF)

'via Blog this'

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Human Errors - cGMP Training

2011-12-05T07:50:00.000-08:00

Learn how to overcome human errors as a root cause to deviations, when human errors are the wrong diagnosis:

Human Errors: Overcoming the Challenges - a SkillsPlus International Inc. training class

Upon class completion, students will be able to:

State what the cGMPs imply regarding human errors.
State the FDA's current thinking about human errors and deviations.
Describe the basics of root cause determination.
List the possible root causes to human errors.

The course covers the following topics:

Introduction
1. Activity: Heard on the street
2. What the FDA says about human errors and deviations
3. How many human errors are too many
4. Recent 483 observations relating to human error

Understanding human error
1. The psychology of human error
2. Sources of human error

Investigating human error
1. Activity: A simple human error
2. 5-Why's
3. Sequence of events
4. Distinctions
5. Walk through analysis
6. Fish bone diagramming and root cause analysis
7. Types of root causes

Preventing human errors
1. CAPA (Corrective Action and Preventive Action)
2. Control barrier analysis
3. CGMP Challenge: Human Errors

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Deviation Investigation Reports - Training Class

2011-11-23T07:50:00.000-08:00

Image via Wikipedia

Many FDA observations are caused by failures in deviation management and CAPA.

We can help you in this area, through this course:
Deviation Investigation Reports - a SkillsPlus Intl Inc. training class

This class teaches students how to use the data collected in an investigation to write a report and answer management and FDA questions.

After completing the class, students will be able to:

Increase investigation report suitability for FDA review.
Decrease the number reports returned by internal reviewers.
Write supported deviation statements.
Provide a detailed background statement to include related information, investigations, affected materials and references.
Document deviation investigation findings.
State the root cause with supporting facts.
Generate supported, plausible, and defensible corrective actions.
Develop effectiveness measures for the corrective actions.
Generate realistic preventive actions.
Develop effectiveness measures for the preventive actions.
Develop a follow up plan for corrective and preventive actions.
Write accurate executive summary statements.

This class is energizing and exciting, and uses the following teaching approaches:

In-house deviation reports will be used to demonstrate and practice the skills and principles of this class.
This course is best taught in a computer lab. We can ship computer labs to your site if needed.
This course is customized to reflect your company procedure on writing deviation investigation reports. As we review that document we will make any recommendations to for change that we feel would be helpful.

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Time To Start Planning Your 2012 cGMP and QSR Training

2011-11-22T07:50:00.000-08:00

The new year is almost upon us.

Don't delay. Get a jump on planning your 2012 training offering.

Check out our training options and offerings on the SkillsPlus International Inc. web site - we're the The Leader in Compliance Training: cGMP, QSR and State Licenses.

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It's Not Too Late To Spend Your 2011 Training Funds

2011-11-21T07:50:00.000-08:00

2011 is coming to an end.

Do you still have 2011 training funds that you need to spend (or lose!)?

Then check out our training options and offerings on the SkillsPlus International Inc. web site - we're the The Leader in Compliance Training: cGMP, QSR and State Licenses.

You might be especially interested in our catalog of engaging & energizing online computer-based training (CBT) courses.

avoid the hassle of coordinating a last minute on-site class
avoid the bother of trying to deal with your trainer's travel expenses, and more
have students take the online classes by computer, without totally disrupting the production line

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Root Cause Analysis - cGMP Training Class

2011-11-16T07:50:00.000-08:00

Learn how to conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries.

Root Cause Analysis for Better Investigations is a live training class. Upon course completion, students will be able to:

Use tools and techniques to effectively identify the deviation statement.
Identify the root cause of the deviation.
Generate and objectively select the best corrective and preventive actions.
Assess the risk of implementing the corrective action and preventive action.
Develop a contingency plan to preventive action implementation.
Create corrective actions and preventive action metrics.

In-house projects will be used to demonstrate and practice the skills and principles of this class.

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Batch Record Review Training - a live cGMP class

2011-11-15T07:50:00.000-08:00

Learn how to review batch records to identify errors and issues.

Faster Product Release Through Efficient Batch Record Review is a live training class. Upon course completion, students will be able to:

State the source of batch record requirements for both US and EU
Distinguish between the production and QA batch record review
List best practices in Batch Record Review
Demonstrate at least 5 different batch record review activities

Pearson VUE: Florida Certified Designated Representative

2011-11-14T07:50:00.000-08:00

Pearson VUE: Florida Certified Designated Representative - Drugs, Devices and Cosmetics: 'via Blog this'

The Pearson VUE website contains specific information about Florida Certified Designated Representative - Drugs, Devices and Cosmetics testing. Register for your next exam, find test information, or download handbooks/applications/forms from this page.

You might be interested in:
Florida Certified Designated Representative Study Course - an online training

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CA HMDR Facilities Must Have Policies and Procedures

2011-11-09T07:50:00.000-08:00

The CA Home Medical Device Retailer (HMDR) licensing program is governed by law sections found in the California Sherman Food, Drug and Cosmetic Law. The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program. The applicable sections can be found in an abstract of the Sherman Law on this CDPH HMDR Sherman Law and FAQ Links webpage.

Section 111656.3 starts out with:

"Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the department pursuant to Section 111656.4, the dispensing of prescription devices. Those written policies and procedures shall be adequate to assure compliance with this article and shall include, but not be limited to . . . "

Notice the phrase, " . . . shall have written policies and procedures . . . "

Not quite sure how to begin, and start writing them?

Then you might be interested in:
Writing Procedures: Drug and Device Wholesalers and HMDR
- an online training course from SkillsPlus International Inc.

Learn to write procedures quickly and thoroughly. Allan shares his experiences and techniques for writing procedures. This class is based on 30 years of experience writing procedures and teaching others to write them. This class is only for drug and device wholesalers, DME's and home medical device retailers. Pharmacists and pharmacy technicians responsible for procedures in their firm may also benefit.

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Find Nearest Test Center for FL Certified Designated Representative Exam

2011-11-08T07:50:00.000-08:00

Find The Nearest Test Center for The FL Certified Designated Representative Exam - Pearson VUE: 'via Blog this'

A link to help you locate a test center near you for the Florida CDR (Certified Designated Representative) Exam.

You might also be interested in:
Florida Designated Representative Study Course by SkillsPlus

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CA Home Medical Device Retailer Exemptee License Application

2011-11-07T07:50:00.000-08:00

Application For CA Home Medical Device Retailer Exemptee License | Designated Representative and Exemptee: 'via Blog this'

The application for the HMDR exemptee is provided for firms who wish to sell prescription Rx devices such as respiratory equipment, medical oxygen and other equipment identified as dangerous or legend devices under California law.

You might also be interested in:
The California Exemptee HMDR and DME Providers Certification Course

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FDA GMP QSR Public Seminar - East or West Coast Location?

2011-11-02T19:40:00.000-07:00

We need your input for planning purposes.

SkillsPlus International Inc. has been proud to offer the CGMP/QSR Trainer Certification Program (a public seminar by SkillsPlus Intl Inc.) for quite a long time without having to cancel a publicized class.

Our students just love this program! Just read some testimonials about SkillsPlus International Inc. training offerings.

We want to make sure there's enough demand for our public seminar in the right places, specifically, East versus West coast.

Here's what we'd like. We need to hear from you!

Is there enough demand to offer our train the trainer certification course on the East, West, or both coasts?

Please sound off by commenting to this post.

Blog Post Updated 12/22/2011:
Announcing our 2012 offering:
cGMP/QSR Trainer Certification Program - a 2012 Public Seminar by SkillsPlus International Inc.

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FL Certified Designated Representative - Oct 2011 Candidate Info Booklet

2011-10-13T19:55:00.000-07:00

Image via Wikipedia

- - - - -
3/11/2012 update.

CAUTION - there are old versions of the candidate information booklet (CIB) that can be found on the internet. Be sure you're referencing the most current version. The most current version, as of today, is the February 2012 edition. Here's how I found it.

Go to the home page of the Florida Department of Business and Professional Regulation: http://www.myflorida.com/dbpr

In the search box, enter "CDR CIB" In the search results, click on "Candidate Information" and there you have it!

For your quick reference, here's the Feb 2012 CDR CIB: http://www.myfloridalicense.com/dbpr/servop/testing/documents/CDR.CIB.pdf
- - - - -

Here's the latest version of the CIB:
State of Florida - Candidate Information Booklet (CIB) for the Certified Designated Representative Laws and Rules Examination - Oct 2011.

Beware, there are older versions out there.

If you're preparing to take the Florida CDR Exam (Certified Designated Representative), make sure you're referencing the latest and most current version of the CIB (candidate information booklet).

While simply Googling, I ran across three different versions of the CIB. One was the outdated October 2010 version, another was dated March 2011.

Bottomline, be sure you find and reference the most current version of the CIB.

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Energizing Online GMP-QSR Training

2011-10-12T20:44:00.000-07:00

Image via WikipediaOnline training gets a bad rap, because there's so much bad stuff out there. Don't settle for simple page turners, or slides of boring content. ... there's better training out there!

Our SkillsPlus International Inc. online training offerings are:

engaging
energizing
exciting

SkillsPlus knows that you expect something social, movie interactive, and NOT BORING!

Check out SkillsPlus International Inc. online training.

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Our New Home Page - SkillsPlus Intl Inc.

2011-10-10T18:30:00.000-07:00

Never stand still.

We've been updating the SkillsPlus International Inc. home page.

The revamp is intended to make it easier for you to navigate to the products or services that you need.

Did we hit the mark?

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Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, etraining, e-training, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

Select e-Learning That Is Pure, Safe and Effective

2011-10-05T07:50:00.000-07:00

Selecting an online e-Learning course is really rather simple.

Identify the course you really need. An Internet search is a great way to learn what is offered.
If they boast about being the least expensive, remember that you get what you pay for. The best business advice I ever got from one of my accountants was, never purchase cheap.
Compare the objectives of each course versus your requirements.
Call the vendor and ask if there is a handout. If not, begin to wonder if the vendor is afraid that the lesson content may not be accurate and not stand up to a critical review.
Ask to see a preview of the course. If they do not offer a free preview, question what they are hiding. Be concerned that you will be paying a lot of money to read a book on your computer screen.

Demand more!

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GMP and QSR Online Computer-Based Training (CBT) by SkillsPlus International Inc.

Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, etraining, e-training, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

An E-learning Black Box Warning: Caution, This Course May Be Hazardous to Your Sanity

2011-10-04T07:50:00.000-07:00

I have taken many e-learning courses over many years.

Recently I purchased an e-learning course that really needed to carry a black box warning: Caution this course may be… After purchasing the class I signed in and after some struggling I finally found the first lesson. I clicked the link that said “start.” Well it did, sort of. A PowerPoint slide popped up. Now, I like PowerPoint if done well. However, this slide was full of text so small that I could not read it except by switching to my large screen monitor. There were two paragraphs of text. Now I must admit that I am getting a little older and perhaps the eye glasses need an update. So I waited for something to happen. I waited and waited, until I realized this was it. Read the text baby. So read I did, clicked continued, and finally got to the quiz. While taking the quiz, I wanted to review some content. No, that was not allowed. I responded to the questions the best that I could. If I missed the answer, the only feedback I got was, Incorrect!.

After one lesson I decided that there had to be a better way to learn. I found someone who offered the course in a true online e-learning environment.

Watch tomorrow’s blog to learn how to choose an e-learning provider.

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GMP and QSR Online Computer-Based Training (CBT) by SkillsPlus International Inc.

Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, etraining, e-training, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

Not All E-learning Is The Same

2011-10-03T19:41:00.000-07:00

Everybody wants to offer online e-learning solutions for their staff training and development needs. But not all e-learning is the same. E-learning should go beyond reading a book on a computer screen. Honestly, if I am going to read the words on a page I would rather be under a fluffy blanket, and be curled up on the couch with a pot of hot tea and some butter cookies. E-learning should make full use of the technology of the computer.

I want the instructor to talk to me, preferably, on the screen.
Add some pictures, or better yet, add some live action video and animation.
Provide some interaction to keep me fully engaged and challenged.
Provide a handout to go along with the course so I can use that as a memory jogger after I have completed the course.

E-learning developers, challenge yourself to go beyond republishing the text book on the computer screen.
E-learning purchasers, demand more from your providers.

Watch for tomorrow’s post for an e-learning black box warning.

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GMP and QSR Online Computer-Based Training (CBT) by SkillsPlus Intl Inc.

Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, etraining, e-training, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

PDA FDA - Interesting Manufacturer Statistics

2011-09-26T07:50:00.000-07:00

At the recent international PDA/FDA meeting, some very interesting statistics were shared. Drug products are manufactured in over 130 countries. In those 130 countries, there are over 300,000 manufacturers. Those manufacturers work through 130,000 importers. It is no surprise that the FDA requires drug manufacturers to audit suppliers and assure that the plant shown is the plant that will manufacturer the drug product. The FDA wants to make sure that there are no "shadow plants" being operated out of CGMP compliance.

To learn more about current GMP rules, visit our website:

SkillsPlus International Inc. - cGMP Compliance Training Experts

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Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, elearning, e-learning, etraining, e-training, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

Ready For Drug Pedigree Rules?

2011-09-22T18:40:00.000-07:00

I recently attended a conference that included representatives from the European, Asian, and U.S. regulatory agencies. At that meeting there was much discussion around pedigree rules.

Some of the concerns expressed begin with importing drugs and bulk actives (now called active pharmaceutical ingredients (APIs)). At this level, manufacturers are required to qualify supplies. This means that a manufacturer must actually visit the API manufacturing site to assure themselves, and the public, that the production facility shown to the auditor is the actual site of manufacture, and that there is no "shadow site" where the real work takes place.

Internationally, there are different approaches to the pedigree. In Europe there is exploration with a "book ends" approach. This approach requires the manufacturer to issue the initial pedigree. The next pedigree touchpoint is at the pharmacy when the product is dispensed to the patient. The thinking is that if the product is moving between known distribution channels, then the product is protected. The U.S. requirement is to document every change in ownership. This means that every touchpoint is documented. Yes, regulators in Europe realize that this approach probably provides better assurance of the supply chain. However, they are also concerned about how much work to pass on to the smaller distributors who may not be staffed for this level of documentation.

Learn more about e-Pedigree in our online computer-based training (CBT) courses:

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Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, elearning, e-learning, etraining, e-training, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

Online GMP Training - 21 CFR 820: Essential Elements

2011-09-19T19:39:00.000-07:00

Image via WikipediaTake this online CBT (computer based training) if you need to review the 21 CFR 820 regulations from the perspective of being inside a medical device manufacturing facility. Learn the rules affecting medical device manufacturing, while getting a glimpse of medical device production techniques.

21 CFR 820: Essential Elements on the Computer-Based Training page by SkillsPlus International Inc.

This class is appropriate for all employees of medical device manufacturing organizations. Upon the completion of the class, employees will be able to summarize the 15 subparts.

Online computer-based training (CBT) is the way to complete required training at minimal cost.

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Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, elearning, e-learning, etraining, e-training, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

FL Certified Designated Representative - Use The Most Current CIB

2011-09-12T07:50:00.000-07:00

Image via WikipediaFL CDR - Caution - Use the most current CIB | Designated Representative and Exemptee: 'via Blog this'

We continue to see two versions of the Florida Certified Designated Representative (CDR) Candidate Information Booklet (CIB) out on the internet.

Make sure you are looking at the most current version of the CIB. There's an older October 2010 version floating around. At the time of this post, there's a more current version, March 2011 that's been published.

Reference:

CANDIDATE INFORMATION BOOKLET for the Florida CERTIFIED DESIGNATED REPRESENTATIVE LAWS AND RULES EXAMINATION COMPUTER BASED TEST (CBT) MARCH 2011

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Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, elearning, e-learning, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

e-Pedigree - CA Board of Pharmacy

2011-09-05T07:45:00.000-07:00

We'll be attending the Sept 7th CA Board of Pharmacy meeting, where one of the agenda items is e-Pedigree ...

CA State Board of Pharmacy - Board and Committee Meeting Agendas and Materials

Updated 12/6/2011:
The minutes finally got posted. You can find them here, and they include:
Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Drug

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Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, elearning, e-learning, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

CA Pharmacy Designated Representative - Online CBT Training

2011-08-29T07:45:00.000-07:00

We offer a very popular online training course, California Designated Representative Training by SkillsPlus International Inc. This program is CBT (computer based training).

You should consider this online training course, because it's so convenient!

It's available to you 24/7, anytime you want.
It's online computer-based training (CBT) that you can take in the comfort of your home or office
There's no need for you to travel!

This class meets the requirements for the State of California Designated Representative.

This is an on-line self-study pre-recorded presentation with animation and text.

Each presentation is followed by the final exam for that section of the class.

Simple FAQs about CA Designated Representative or Interactive FAQs about CA Designated Representative about this training course

Enroll now - California Designated Representative Certification Class 006 by SkillsPlus International Inc.

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GMP-QSR Trainer Certification Public Seminar - 1 seat left

2011-08-25T18:53:00.001-07:00

We want to see you!

Don't miss out. This popular course is almost sold out, 2011 GMP/QSR Trainer Certification Program by SkillsPlus International Inc.

There's only 1 (one) seat left. Sign up quick before we close this annual public seminar.

Blog Post Updated 12/22/2011:
Announcing our 2012 offering:
cGMP/QSR Trainer Certification Program - a 2012 Public Seminar by SkillsPlus International Inc.

SkillsPlus Intl Inc. Home
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Problems With Standard Operating Procedures? We've Got Templates

2011-08-22T18:20:00.000-07:00

Are you struggling with writing standard operating procedures (SOPs)?

Then we've got your solution!

Check-out our online CBT (computer-based training) course. Once you sign-up to take the course, your course will include some SOP templates that you can use, Writing Procedures: Drug and Device Wholesalers and HMDR (make sure to scroll down to the bottom of the page).

Return to info blog home: http://www.skillsplusinfo.blogspot.com/

Go to our website: http://www.skillsplusinc.com/

Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, elearning, e-learning, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, WBT

Florida Certified Designated Representative Glossary Gadget

2011-08-20T09:10:00.000-07:00

Are you studying for the Florida Certified Designated Representative (FL CDR) exam?

Then use our free Florida Certified Designated Representative glossary widget (by SkillsPlus International Inc.) to search for terms and definitions. The previous hyperlink is provided because this blog page might limit how much of the widget to display.

CA HMDR Exemptee - Online Training and Certification

2011-08-15T17:01:00.000-07:00

We offer this online CBT (computer based training), Exemptee Certification California HMDR and DME Providers.

This training program is intended for employees that must meet the required knowledge and training mandated by California Health and Safety Code and the associated Home Medical Device Retailer (HMDR) Licensing Program. The CA HMDR Program licenses all California and Out-of-State facilities and businesses who supply medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries.

Upon successful completion of this web-based course, you'll submit your request to us for training documentation (that prompts us to complete and mail your Certificate of Completion).

California Home Medical Device Retailer (HMDR) FAQs

GMP-QSR Trainer Certification Public Seminar - 2 seats left

2011-08-03T18:22:00.000-07:00

Act now!

There are only two (2) seats left in our 2011 GMP/QSR Trainer Certification Public Seminar by SkillsPlus International Inc. This course is offered once a year, and it's almost sold out.

Get off the fence now, and register!

Blog Post Updated 12/22/2011:
Announcing our 2012 offering:
cGMP/QSR Trainer Certification Program - a 2012 Public Seminar by SkillsPlus International Inc.

Florida Certified Designated Representative (FL CDR) Exam Prep

2011-08-02T07:45:00.000-07:00

Preparing to take the Florida Certified Designated Representative (FL CDR) Exam is challenging.

So what you need are some solid exam preparation tools, including this Florida Certified Designated Representative (FL CDR) glossary widget by SkillsPlus International Inc.

If you have any questions about what a term means, chances are you'll find the definitions here!

Enjoy!

How To Train Other GMP-QSR Trainers

2011-08-01T07:45:00.000-07:00

If you're responsible for training other GMP or QSR trainers, then here are some things that are important to you:

Having a mastery of the FDA regulations that must be taught
Demonstrating a command of adult learning principles, and
How to deliver compelling and engaging training sessions

If you're looking to improve or acquire these skills, then don't miss out on:

GMP-QSR Trainer Certification - a public seminar by SkillsPlus International Inc.

Overcoming The Documentation Nightmare CBT - Info On One Page

2011-07-28T18:55:00.001-07:00

We're listening to you.

We've made it a little easier for you to find information and details about our Overcoming the Documentation Nightmare CBT by SkillsPlus International Inc. Consolidated information about the class now appears on its own dedicated page.

If your plant site experiences high documentation deviation rates and needs to drive that rate down, take a look at this computer-based training course. Clear explanations of current documentation rules are provided. Numerous opportunities for students to challenge their knowledge and retention of information keeps students engaged.

This online course was designed for affordability, and quick teaching time, which fits into the training schedules of most sites.

CA Pharmacy Designated Representative Training - Very Popular

2011-07-26T19:25:00.000-07:00

Learn more about our very popular online training course, California Designated Representative Training by SkillsPlus International Inc.

You need to take this online training course, because it's so convenient!

It's available to you 24/7, anytime you want.
It's online computer-based training that you can take in the comfort of your home or office
There's no need for you to travel!

Learn the requirements of a Designated Representative for the State of California. This class meets the requirements for the State of California Designated Representative. This is an on-line self-study pre-recorded presentation with animation and text. Each presentation is followed by the final exam for that section of the class. This class allows you to study from the convenience of your home or office.

Simple FAQs or Interactive FAQs about this training course

Enroll now - California Designated Representative Certification Class 006 by SkillsPlus International Inc.

GMP & QSR Trainers Must Be More Than Just Subject Matter Experts

2011-07-23T13:10:00.000-07:00

Image via Wikipedia

Trainers must be skilled!

They must be expert course designers and facilitators
They must pay attention to the experiential learning process
They must keep students involved, engaged, and energized

It’s a given that GMP & QSR trainers must have mastery over the regulations that they are teaching. Mastering applicable laws, regulations, directives, standards, guidance, and compendia for manufacturing biologics, drugs, dietary supplements, and medical devices is essential for raising your company’s employees and management team compliance competency.

GMP & QSR trainers must also be able to help others expand their knowledge of relevant regulatory requirements, and to help others apply that knowledge in the workplace.

What does that mean?

It means that trainers must have the skills needed to teach others. We often find that trainers, program designers, training supervisors, training managers, and others who conduct GMP or QSR training in the pharmaceutical, biotech, medical device or dietary supplement industries need help in developing their training skills.

Expert GMP & QSR trainers:

Focus on experiential learning processes
Teach in a facilitation and learning style that’s appropriate to particular regulatory topics
Design and facilitate learning activities
Facilitate meaningful discussions, and create safe environments through the debrief process
Model different teaching strategies
Tell compelling case stories
Keep students involved, engaged, and energized

If you think you or a member of your team needs help in developing training skills, then consider attending this annual course, GMP-QSR Trainer Certification Public Seminar by SkillsPlus International Inc.

Value-Packed - Overcoming the Documentation Nightmare CBT Class by SkillsPlus International Inc.

2011-07-22T07:22:00.000-07:00

Our SkillsPlus International Inc. - Overcoming the Documentation Nightmare CBT Class (pdf) is intended to raise compliance awareness, and raise compliance issues for further discussion at your company.

You need this value-packed class!

It offers high-quality online instruction from the most respected trainer in the industry
You can take this class any time you want, at your own convenience
For the quality and price, you can't beat the value of this class

We've designed this online course to make sure students don't get bored. The class includes video taken in a real manufacturing plant, and there are interactive quizzes with a final exam.

This computer-based class offers both depth and breadth in the main topics and sub-topics to make sure that all essential topics get covered:

Introduction - 483 observations related to documentation practices
Documentation Practices - entry, error correction, unacceptable practices, prohibited practices, falsification
Data Handling - rounding
Electronic Records - general requirements, reliability
Electronic Record Access - biometrics, authority checks, access controls
Electronic Record Security - system breach, time-out
Electronic Record Integrity - audit trail, record protection, record integrity
FDA and Documentation - request for documents, record retrieval, retention time

You need to take this value-packed class.

Go to our CBT Training webpage, and sign-up for Skillsplus International Inc. - Overcoming the Documentation Nightmare CBT Class

Why You Need Proper Documentation Practices Training

2011-07-20T20:10:00.000-07:00

You’re probably asking yourself, “What’s in it for me?”

Well, are you having troubles with:

Proper documentation practices?
Error correction?
Unacceptable documentation practices?
Trying to discern electronic documentation requirements?
Documentation deviations?

If you answered yes to any of the above, then you need our CBT series training course:

SkillsPlus International Inc. - CBT Series - Overcoming the Documentation Nightmare

Trainer Certification Testimonials - SkillsPlus International Inc.

2011-07-19T19:53:00.000-07:00

Read what our past students have said about our classes:

"Best course I've ever attended."
"This class has changed my training life."
"First seminar I ever attended where I didn't want to leave early."
"I never knew that GMP training could be so much fun."
"I have so many new ideas about how to conduct GMP training back home."
"I can use everything I learned in this class to make my training more effective."

Former students, we encourage you to use the comment feature to add your testimonial to this thread.

GMP-QSR Trainer Certification Public Seminar by SkillsPlus International Inc.

About Computer-Based Training (CBT) by SkillsPlus International Inc.

2011-07-17T08:52:00.000-07:00

Skillsplus International Inc. computer-based training (CBT) is the way to complete required training at minimal cost. We offer the CBTs in different flavors according to your training needs, so you can choose from any one of the following approaches:

Watch Now - Pay per view, then view the training in our virtual classroom

Movie - We'll send you a data-disk that you can play on your computer

Interactive - We'll send you a data-disk that you can play on your computer. This approach offers more than the Movie version by engaging the learner with interactive quiz questions.

LMS - We'll send you SCORM-compliant or AICC-compliant files of the course for you to install in your company learning management software system.

View the collection of SkillsPlus International Inc. Computer-Based Training Offerings

Fun things to do while you are here for the Public Seminar

2011-07-16T09:40:00.000-07:00

Image via WikipediaAs you start planning your itinerary to attend the SkillsPlus Intl Inc. - GMP/QSR Trainer Certification Public Seminar, consider adding these fun things to do during your stay in San Francisco.

San Francisco Fleet Week - Air shows, ship tours, and more! - Oct 6-10

143rd Annual Italian Heritage Parade and Celebration - Oct 9

And don't forget about all the great things you can do in and around San Francisco like, riding the cable cars, shopping at high-end stores around Union Square, eating at the best restaurants, visiting the wine country, going to the must see tourist spots like the Golden Gate Bridge, and so much more. Get your inspiration by visiting the San Francisco's Visitor Information Center, just down the street from the Public Seminar hotel.

GMP Trainer Certification Public Seminar - Details

2011-07-10T07:38:00.000-07:00

For your quick reference here's more information, in the brochure, for this public seminar:

SkillsPlus Intl Inc. - Public Seminar - GMP & QSR Trainer Certification - Pharmaceutical, Biotech, Medical Device, and Dietary Supplement Industries (PDF)

Here are some highlights:

Who: Presented by SkillsPlus International Inc.

What: GMP/QSR Trainer Certification - a public seminar. This is a five-day class in which participants experience many different ways to teach GMPs and QSRs. Then learn what your instructor is thinking about during sessions so that you can repeat that training approach in your organization. Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also.

When: October 10-14, 2011

Where: San Francisco, CA

How: Follow the link to Register On Line - Enroll/Register

Blog Post Updated 12/22/2011:
Announcing our 2012 offering:
cGMP/QSR Trainer Certification Program - a 2012 Public Seminar by SkillsPlus International Inc.

Blog Post Updated 9/9/2011:

I'm leaving this quick note to let you know that this year's 2011 GMP/QSR Trainer Certification Program - A Public Seminar by SkillsPlus International Inc. is sold out. We've started a waiting list. When we schedule the next public seminar, we'll send out an early notice to folks on the waiting list. We also maintain a Public Seminar webpage, that we'll update as soon as details for the next seminar start to solidify: http://www.skillsplusinc.com/Pub_Sem.htm

Allan Dewes

GMP Trainer Certification Public Seminar - Seats Going Fast

2011-07-09T18:10:00.000-07:00

Don't delay!

Seats are going fast for this public seminar:

SkillsPlus Intl Inc. - Public Seminar - GMP/QSR Trainer Certification

Don't miss this annual event!

Blog Post Updated 12/22/2011:
Announcing our 2012 offering:
cGMP/QSR Trainer Certification Program - a 2012 Public Seminar by SkillsPlus International Inc.

Blog Post Updated 9/9/2011:

Allan Dewes

New - Overcoming the Documentation Nightmare (CBT)

2011-07-09T11:13:00.000-07:00

Learn more about this SkillsPlus Intl Inc. computer-based training: Overcoming the Documentation Nightmare

Hello world!

2011-07-09T10:27:00.000-07:00

We're here! Hello world!