Showing posts with label 2014. Show all posts
Showing posts with label 2014. Show all posts

Wednesday, November 13, 2013

GMP Training Suggestions for 2014 - cGMP Essentials Course

 
 
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! 
  1. Do you need to get CGMP and related training completed and do not have the staff, or
  2. Are you and your staff already overloaded, or
  3. 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.
 

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!
 

 
Allan Dewes
Allan Dewes, President.
 
About Your Instructor
Allan Dewes
 
Allan Dewes has been training employees for over 40 years, with 30 years in the pharmaceutical industry. Allan understands CGMP regulations, the FDA expectations, and how to make training fun to maximize retention.
 
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Wednesday, October 30, 2013

2014 GMP Training Ideas - Root Cause Analysis of Deviations Workshop

2014 GMP Training
Root Cause Analysis of Deviations:

This course is more than idle chat. In this workshop, students apply root cause analysis tools to real in-plant deviations.

Tools addressed in this very popular workshop:
1. 5-Whys In-Depth Map
2. Sequence of Events
3. Distinctions
4. Walk-Through Analysis
5. Change Analysis
6. Control Barrier Analysis
7. Fishbone Diagrams and more!

If your firm is not satisfied with the quality of deviation investigations, then you need to look into our Root Cause Analysis of Deviations workshop!

Follow this link to learn more about our Root Cause Analysis of Deviation Workshop (a GMP training course)

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 

Monday, April 25, 2011

FDA Priorities For 2011-2015

Updated February 2, 2021:

The U.S. Food and Drug Administration (FDA) today released the final version of a strategic priorities document outlining the goals that will guide the agency and its 12,000 employees through 2015, FDA’s “Strategic Priorities 2011 – 2015: Responding to the Public Health Challenges of the 21st Century” - PRNewsWire.

It conveys the FDA's vision for the future, by mentioning:
  • a modernized field of regulatory science that draws on innovations in science and technology to help ensure the safety and effectiveness of medical products throughout their life cycles
  • an integrated global food safety system focused on prevention and improved nutrition
  • expanded efforts to meet the needs of special populations.
The document is organized into four major sections:
1.0 Introduction 
2.0 Cross-Cutting Strategic Priorities
3.0 Strategic Goals and Long-Term Objectives
4.0 Implementation


You might also be interested in:
Strategic Priorities Blog posting by FDA Commissioner Margaret A. Hamburg

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