Root Cause Analysis for Better Deviation Investigations - GMP Training

Root Cause Analysis for Better Deviation Investigations - A cGMP Training Course

A top reason why companies receive a 483 is a deficiency in the deviation investigation process. In our experience, most employees need deviation investigation training, and here's why:

• Staff struggle to solve problems
• Teams often fail to get results
• The pharma and biotech sector repeatedly demonstrate difficulty in complying with FDA expectations for thorough deviation investigations.

In this SkillsPlus International Inc. hands-on workshop, employees learn the most effective tools to determine the real root cause of the problem. Attendees use actual plant deviations to practice the use of the tools. Allan Dewes, the lead instructor, has taught this course all over the world with exceptional results.

Call (415) 948-5220, or learn more: http://www.skillsplusinc.com/root_cause.htm

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  Qualstar Simulation - An Advanced CGMP Training Course

Qualstar Simulation - An Advanced CGMP Training Course

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

Qualstar: A Pharmaceutical Simulation (cGMP Training)

Having problems with documentation, following procedures, change control or deviations?

In this GMP training course, employees work in small teams in this unforgettable 3-4-hour industry simulation. The importance of documentation, procedures, change controls & deviations are stressed through competition, citations, fines, injunctions, and in some cases, even jail terms. A very short lecture component is customized to address your site’s specific compliance needs.

This cGMP training course excites, energizes, & engages students! Training content covers documentation, following procedures, change control, deviations, & more.

Learn more about this course: http://www.skillsplusinc.com/qualstar.htm

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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  Advanced GMP Training For Leaders - The Executive Session
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Advanced cGMP Training For Leaders & Top Management

Advanced GMP Training For Leaders - Our "Executive Session" course is designed for executives & management teams.

It's hard to get busy executives into GMP training (even with the FDA citing companies for their executive team’s lack of CGMP training).

• This course is designed for leaders with busy schedules. 
• Lasting 1-4 hours, this onsite class reviews current citation trends & compliance issues that are important to executive and management teams. 
• This course is completely customized for your company. 

Call (415-948-5220) to discuss your training needs.
Learn more about Executive Session - Advanced GMP Training

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If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

Our most popular course

Put fun back into GMP training!

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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  Advanced GMP Training For Leaders - The Executive Session

GMP Olympics - cGMP Training

Updated January 18, 2023

The following course is no longer available:

GMP OLYMPICS - GMP Training

So your team thinks they “know it all” about CGMPs? This course puts them to the test!

This cGMP Olympics course tests their knowledge of the regulations during one day of these highly interactive activities:

• Heard On the Street
• CGMP Speed Dash
• CGMP Challenge, and 
• Inspection Detection 

Everyone learns something new in class!

Instead, you might also be interested in our online training programs and courses: GMP Training by SkillsPlus Intl Inc.

GMP Essentials for Drug Manufacturers - Onsite cGMP Training

Updated July 16, 2021

FDA GMP QSR Online Training Courses by SkillsPlus Intl Inc.

- -   original post follows below   - -

GMP Essentials for Drug Manufacturers - An Onsite GMP Training Course
This course is appropriate for new employees, or to meet the needs of current staff and refresher training. This highly interactive course gets everybody involved talking about current CGMP practices and the consequences of non-compliance. Many CGMP principles are experienced hands-on in this course. Usually customized to meet the needs of the organization, this session can last from one to three days. Call Allan Dewes at SkillsPlus International Inc., (415) 948-5220, to discuss your specific needs and the instructor's recommendations.

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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GMP Training Ideas - Executive Session

• You might also be interested in FDA CGMP online training courses and programs taught by SkillsPlus International Inc.

Updated August 10, 2024

The "Executive Session" course is no longer available.

Additional online class offerings can be viewed, by following the link above.

---  the original post follows below  ---

483 Observation Gotchas!   1. Firm lacked an effective training program to ensure all employees, including upper management, are fully trained on CGMPs. 2. Management failed to prevent non-controlled documents from being in the dispensing area. 3. Management did not understand their role & responsibility in supporting & enforcing the quality system.            Planning for Training 2014!  2014 is just around the corner!  Can't get management staff to attend your CGMP training sessions, or Not quite sure what to present to management staff for annual CGMP training, or Does management feel that they do not need to attend annual CGMP training? If you answered "Yes" to one or more of these questions, then you need to take a look at our Executive Session 2014 CGMP Update.    Featured Course Executive Session 2014 CGMP Update: This course focuses on what the executive needs to know. There's no discussion of "single-line through ... yada, yada, yada," in this course.   Topics addressed in this intense update: 1. Annual observation update 2. What the observations mean to executives and managers 3. Consequences 4. Interesting court cases 5. Current trends and more!   If your firm needs to get some of your executives and managers into meaningful CGMP training, then you need to look into our Executive Session 2014 CGMP Update!   Return Home: The Health, Drug, Prescription, and GMP Supersite Blog SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors SkillsPlus Intl Info Blog The Exemptee Institute The Designated Representative Institute The Health, Drug, Prescription, and GMP Supersite Gift Store