FDA - Proposed 2016 Guidance Development & Focused Retrospective Review of Final Guidance

According to the FDA:

" . . .guidance documents that CDRH intends to publish this fiscal year (FY2016), as well as previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn. We have provided three lists: (1) a list of guidance documents that the Agency fully intends to publish (the “A-list”); (2) a list of guidance documents that the Agency intends to publish as resources permit (the “B-list”); and (3) a list of final guidance documents that issued in 2006, 1996, 1986, and 1976 subject to focused retrospective review."

Go to this FDA webpage:
CDRH Fiscal Year 2016 (FY 2016) Proposed Guidance Development and Focused Retrospective Review of Final Guidance


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Root Cause Analysis - GMP Training

Advanced GMP Training - The Qualstar Pharma Simulation

QUALSTAR - PHARMACEUTICAL SIMULATION (GMP TRAINING)

This cGMP training course excites, energizes, & engages students! --- Topics cover documentation, following procedures, change control, deviations, & more.

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Learn more:  QUALSTAR - PHARMACEUTICAL SIMULATION (GMP TRAINING)

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GMP Olympics Annual Update - cGMP Training

• Buy now! FDA GMP online training courses sold by SkillsPlus International Inc.

Updated September 18, 2023

The Olympics course is no longer available.

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The best and recommended choice for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.

---  the original post follows below  ---

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 
• Inspection Detection 

Everyone learns something new in class!

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FDA GMP Training by SkillsPlus International Inc.

If  you've got training needs, we've got the courses and classes for you!

Checkout cGMP online training courses by SkillsPlus International Inc.

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Qualstar Simulation - Advanced QSR & GMP Training Onsite

Qualstar Simulation: CGMP or QSR Advanced Onsite Training Course by SkillsPlus Intl Inc

This highly interactive on-site training class is action packed and keeps students energized. Students actually have fun while learning!

This is an instructor led course taught onsite, in-house, at client locations.  Students learn about the importance of documentation, procedures, change control and QA.

By the end of class, participants will be able to:

1. demonstrate proper documentation practices. 
2. experience the value of well-written procedures. 
3. demonstrate proper actions when procedures contain errors. 
4. experience the value of the quality unit.

Get your employees excited about learning and training with this exciting and engaging class!

Learn more about this live training class:

Qualstar Simulation: CGMP or QSR Advanced Onsite Training Course by SkillsPlus Intl Inc

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