GMP Training - The cGMP Essentials Course

Updated October 31, 2024

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CGMP Training: A New Generation - Course Descriptions - Training by SkillsPlus International Inc.

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483 Observation Gotchas!   1. There is no documented training in CGMPs. 2. CGMP training has not been conducted for over three years. 3. Firm lacks qualified CGMP trainers.      Planning for Training 2014!  2014 is just around the corner!  Do you need to get CGMP and related training completed and do not have the staff, or Are you and your staff already overloaded, or Do you just need a new and exciting approach to CGMP training? If you answered "Yes" to one or more of these questions, then take a look at our CGMP Essentials course. Learn More About the SkillsPlus CGMP Essentials course   Featured Course CGMP Essentials: This course can be structured with more than two dozen different training activities designed to reinforce learning and keep employees engaged. Prior students have high praise. One manager said, "I never knew CGMP training could be so much fun." One former FDA Inspector reported, "I actually learned something."   Topics addressed in this very popular course: 1. Heard on the Street 2. Review of 21 CFR 211 Subparts 3. Essential Quality System Tools 4. Consequences for non-compliance, and more!   If your firm needs a fresh new look at CGMP training, then you need to look into our CGMP Essentials course!   Examine The CGMP Essentials Course Outline

ICH Increases Transparency - Publishes Its New Procedures Manual

ICH Looks to Increase Transparency of its Activities, Processes with New Procedures Manual:

"The International Conference on Harmonisation (ICH), a pharmaceutical regulatory harmonization body consisting of regulators from the US, EU and Japan, is publishing new documents intended to explain in full detail exactly what goes on within its regulatory black box."

For your reference:
ICH Procedures (PDF)

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

Batch Record Review Training - a live cGMP class

• People also prefer online training - FDA CGMP online training courses provided by SkillsPlus International Inc.

Updated August 17, 2022

The batch record review course is no longer available.

You might also be interested in our other cgmp online training programs and courses.

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GMP Training - Batch Record Reviewing - cGMP Training

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:

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

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

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