Monday, February 27, 2012

Essentials for Medical Device Manufacturers - Live onsite QSR training class

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
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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:
  1. Increase investigation report suitability for FDA review. 
  2. Decrease the number reports returned by internal reviewers. 
  3. Write supported deviation statements. 
  4. Provide a detailed background statement to include related information, investigations, affected materials and references. 
  5. Document deviation investigation findings. 
  6. State the root cause with supporting facts. 
  7. Generate supported, plausible, and defensible corrective actions. 
  8. Develop effectiveness measures for the corrective actions. 
  9. Generate realistic preventive actions. 
  10. Develop effectiveness measures for the preventive actions. 
  11. Develop a follow up plan for corrective and preventive actions. 
  12. 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:

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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
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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 . . .

  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. 

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
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Tuesday, February 14, 2012

Creating CGMP and QSR Responsibility and Accountability - Onsite Training Class

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:
  1. Review the CGMP/QSR Regulations. 
  2. Set climate for a compliance discussion. 
  3. Create a compliance message. 
  4. Provide behavioral feed back. 
  5. Create responsibility for CGMPs and performance. 
  6. Establish an atmosphere of accountability. 
  7. 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,

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Monday, February 13, 2012

Follow SkillsPlus Intl Inc via Constant Contact

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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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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Tuesday, February 7, 2012

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

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:
  1. Regulation review 
  2. US & EU Requirements and Regulatory Expectations 
  3. Best Practices 
  4. BPR Regulations Background 
  5. BPR Audit Items: Skills Practice 
  6. Trending
For more information, visit:

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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,

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