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Friday, January 2, 2015

GMP QSR cGMP Training Course Catalog - by SkillsPlus Intl Inc.

Updated March 10, 2021

With the COVID-19 pandemic all around us, people also search for:
Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

- - -

Get ready for the coming year's cGMP QSR GMP training

Are you planning your CGMP training schedule for the coming year?
Do you wish you had more instructors?
Do you need more time to develop the courses?

If you answered yes to any of the questions above, then take a look at our current list of classes, courses, workshops, and seminars that we can bring to your plant site.

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

Friday, April 12, 2013

Root Cause Analysis for Better Deviation Investigations - Onsite Courses - Popular

These highly popular cGMP & QSR training classes are taught at the location of your choice, as a client on-site in-house training. You might be interested in two of our highly inter-related courses.

Root Cause Analysis for Better Investigations, and
Deviation Investigation Reports

- - - FIRST - - -

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'

- - - SECOND - - -

Deviation Investigation Reports: On-Site Training by SkillsPlus International Inc.:

Purpose:

To use the data collected in an investigation to write a report and answer management and FDA questions.

Objectives

Increase investigation report suitability for FDA review.
Decrease the number of 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.

About the Class

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.
The optional final exam is approximately 25 questions.
Each student receives a student guide containing a representation of the program's slides and graphics with space provided for note taking.
This class can accommodate up to 12 people.
Duration: 8 hours as a minimum.

For more information:

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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

Tuesday, January 15, 2013

QSR GMP Trainer Certification

Updated December 19, 2025

Did you miss our public seminar?

We offer the online self-study version:
GMP Trainer Awareness, Certification, & Master Trainer Course

--- original post follows below ---

You've been clamoring for our public seminar at an East Coast location, so here we are!
Visit warm and sunny Fort Lauderdale, FL in May, for this highly recommended public seminar course.

Average Weather In May For Fort Lauderdale, Florida

Register soon to qualify for an early registration discount.

This is the most popular trainer certification course on the market!

Learn how to train CGMPs and QSR courses from successful compliance professionals
Experience, practice, and master the skills to make compliance training fun, informative, and exciting

Graduates of this course say that attending this public seminar is a life-changing event!

Overview:

This is a five-day public seminar that leads participants through 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 two presentations demonstrating their skills during the class. This class is also suitable for food and dietary supplement manufacturers.

Course Details:

Brochure - QSR-cGMP Trainer Certification Course - A Public Seminar Offered by SkillsPlus Intl Inc.

Participants will learn how 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 reinforce learning.
Facilitate discussions and questions like a pro.
Respond to difficult questions.
Deal successfully with difficult students.
Manage classroom media

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Monday, December 31, 2012

The Exemptee Institute just launched

California HMDR Exemptee Training - for home medical device retailers. Online training certification by SkillsPlus International Inc. - If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate for your license application.

SkillsPlus International Inc. has just launched a new website, The Exemptee Institute, to help California Exemptee applicants and home medical device retailers (HMDR) get the information they need quickly.

Check out our new site: http://www.exemptee.org/

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----------

California HMDR Exemptee Training - for home medical device retailers. Online training certification by SkillsPlus International Inc. - If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate for your license application.

California HMDR Exemptee Training - for home medical device retailers

. Online training certification by SkillsPlus International Inc. - If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate for your license application.
SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Tuesday, December 18, 2012

Free Tips - GMP Master Training Plan - QSR Master Training Plan

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Thursday, November 29, 2012

GMP Training - It's Time To Start Planning

FDA cGMP QSR GMP Training - online training courses by SkillsPlus International Inc.

Updated December 6, 2025

GMP Training - cGMP Training - Plan your upcoming year!

It's time to start planning your upcoming new year QSR and cGMP training, and consider engaging SkillsPlus International Inc. as your external trainer.

Tackle the new year now! Coordinating future training is involved, so get ahead of the new year before it arrives. Waiting to start planning conversations in the new year only perpetuates delays, and contributes to pushing off training to the last minute.
Send the right message! By delaying early planning for next year's training, there's a risk of sending unintended and unspoken messages that training isn't very important.
Deliver the best training! Brainstorm your training needs with the leaders in GXP compliance training. Sometimes discussing things with, or bringing in external trainers can ratchet up the quality of training that students will experience. SkillsPlus International Inc. is a leader in compliance training, having trained thousands of students, over more than 30 years. Past students rave about the engagement and interactivity experienced in SkillsPlus courses.

Partner now with SkillsPlus International Inc. for your upcoming year's QSR & GMP training needs, to ensure that your Master Training Plan delivers timely quality training programs throughout the coming year. Simply visit our website to get started:

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

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Tuesday, April 3, 2012

QSR & GMP Public Seminar - Trainer Certification - SkillsPlus

Updated December 16, 2020

Tuesday, March 27, 2012

SkillsPlus Intl Inc - cGMP & QSR Compliance Experts - Word Cloud

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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

Wednesday, March 21, 2012

Onsite cGMP Training - Olympics for Pharmaceutical & Biotech Manufacturers

Updated June 5, 2021

Given the COVID-19 pandemic, people are also interested in:

FDA GMP Online Training - respected FDA CGMP online training courses presented by SkillsPlus International Inc.

--- original post follows below ---

Onsite cGMP Training - Olympics for Pharmaceutical & Biotech Manufacturers - by SkillsPlus International Inc.

How many boring training classes have you and your colleagues been through?!

Say NO to boring training. Experience exciting, energizing, and engaging training!

Take a deep dive to a deeper level of understanding through a series of challenging activities.

By the end of this class, energized students will be able to:
1. List the hottest issues in CGMP compliance.
2. Locate items of interest in 21CFR211.
3. Explain the 21CFR211 rationale for specific 483 observations.
4. Demonstrate knowledge of common CGMP practices and details.
5. State the consequences of not following CGMPs.

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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

Wednesday, March 14, 2012

ISO 17025: Calibration Laboratories - Onsite Training Class

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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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

Monday, March 12, 2012

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

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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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

Wednesday, March 7, 2012

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

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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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

Monday, March 5, 2012

Executive Session: What Leadership Needs to Know - cGMP training

Updated February 18, 2025

The Executive Session course is no longer available.

Tuesday, February 21, 2012

Deviation Investigation Reports - Live onsite cGMP & QSR training class

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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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

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

Saturday, February 18, 2012

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

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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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website
Additional Keywords: biotech, cGMP, class, compliance, course, device, drug, FDA, GMP, instructor, interactive, International, manufacturer, medical, pharmaceutical, QSR, seminar, SkillsPlus, training

Tuesday, February 14, 2012

Creating CGMP and QSR Responsibility and Accountability - Training Class

Updated July 1, 2025

The original link broke.

--- original post follows below ---

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

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

Monday, February 13, 2012

Follow SkillsPlus Intl Inc via Constant Contact

FDA cGMP QSR GMP Training - online training classes taught by SkillsPlus International Inc.

Updated October 26, 2020

Links broke in the original post below.

You might also like to visit the SkillsPlus International Inc. website.

- - - original post follows below - - -

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

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

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Tuesday, February 7, 2012

Faster Product Release Through Efficient Batch Record Review - Onsite cGMP & QSR Training Class

Updated March 17, 2023

The batch record review course is no longer available.

You might also be interested in FDA cGMP online training programs and courses offered by SkillsPlus International Inc.

--- the original post follows below ---

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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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

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

Monday, January 30, 2012

cGMP/QSR Trainer Certification

Updated March 14, 2021

Wednesday, January 25, 2012

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

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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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

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

Disclaimer

The Leader in Compliance Training: FDA, CGMP, QSR, Exemptee, and Designated Representative training courses. Students love our interactive on-site training classes, and the convenience of our internet-based e-Learning courses. www.skillsplusinc.com

The views expressed in the posts and comments of this blog do not necessarily reflect SkillsPlus International Inc. They should be understood as the personal opinions of the author. They should not be construed as consulting advice. No information on this blog will be understood as official. All data and information provided on this site is for informational purposes only. Skillsplusinfo.blogspot.com makes no representations as to accuracy, completeness, currentness, suitability, or validity of any information on this site and will not be liable for any errors, omissions, or delays in this information or any losses, injuries, or damages arising from its display or use. All information is provided on an as-is basis.

Comment Policy

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Participants on this blog are fully responsible for everything that they submit in their comments, and all posted comments are in the public domain.

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