2014 GMP Training Ideas - GMP Olympics Refresher Course

Updated September 26, 2022

The GMP training course described in the original post is no longer offered.

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FDA GMP online training programs and classes offered by SkillsPlus International Inc.

---  the original post follows below  ---

Plan for cGMP Training 2014!  2014 is just around the corner!  Do your employees avoid CGMP training, claiming they've heard it all, or Do they resist attending CGMP training because "their" job is never discussed, or Do some employees "drift off" in CGMP training because it is too theoretical? If you answered "Yes" to one or more of these questions, then you need to take a look at our GMP Olympics Refresher course.

Featured Course GMP Olympics 2014: Become a participant in the Olympics! This course challenges even the most seasoned employee's knowledge of CGMPs. This course is definitely not for new employees who are new to the industry. Activities from this highly interactive workshop: 1. Heard on the Street 2. Team-based regulation review 3. GMP Challenge 4. Inspection Detection, and more! This course can be customized to meet a variety of content and time constraints. Examine the GMP Olympics 2014 Course Outline 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. Email today to request a quotation

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2014 GMP Training Recommendation - Root Cause for Deviation Investigations Workshop

Do your firm's   Planning for Training 2014!  2014 is just around the corner!  Do your firm's investigations conclude no assignable root cause, or Do your firm's investigations conclude the root cause was human error, or Do your investigations fail to identify product impact? If you answered "Yes" to one or more of these questions, then take a look at our Root Cause for Deviation Investigations workshop.

 

Featured Course 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!   Examine The Root Cause Analysis - Investigation of Deviations Outline      Allan Dewes, President.   About Your Instructor Allan Dewes Allan Dewes has worked on deviation investigations and trained others to do the same for over 30 years. Allan understands CGMP regulations, the FDA expectations, and how to make deviation training effective and fun.   Email today to request a quotation

 

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FDA Releases ICH Draft Guideline on Elemental Impurities

• FDA GMP Online Training - respected CGMP online training classes offered by SkillsPlus International Inc.

Updated February 14, 2021

Links broke in the original post.

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ICH HARMONISED GUIDELINE - GUIDELINE FOR ELEMENTAL IMPURITIES - 

Q3D(R1) - ICH Consensus Guideline (PDF)

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US FDA Releases ICH Draft Guideline on Elemental Impurities - Outsourcing-Pharma.com:

"The guideline consists of three components: the evaluation of the toxicity data for potential elemental impurities, the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern, and development of controls designed to limit the inclusion of elemental impurities in drug products to levels at or below the PDE."

Follow this link to the guidance:  INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE - DRAFT CONSENSUS GUIDELINE - GUIDELINE FOR ELEMENTAL IMPURITIES - Q3D (pdf)

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GMP Training - Plan For Next Year - Buy "Qualstar Simulation"

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

Planning for Training 2014!

 2014 is just around the corner! 

1. Do CGMP documents contain many errors, or
2. Are change controls often side-stepped, or
3. Is the Quality Unit often side-stepped, or
4. Are procedures not always followed?
   
   If you answered "Yes" to one or more of these questions, then take a look at our 2014 Qualstar: A CGMP Training Simulation course. 

Featured Course (this course has been discontinued)

Qualstar - A CGMP Simulation: Designed to teach and to change the culture of companies in order to focus on quality and compliance. This competitive simulation is an eye-opener for participant and executive staff observers alike.

 

Issues addressed in this exciting simulation:
1. Documentation problems

2. Procedures not being followed

3. Change control not practiced

4. QA not consulted on deviations

 

If this describes some of your issues, then you need to experience Qualstar!

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The Park Doctrine Resurrected | Managers, Corporation Can Be Prosecuted

FDA (Food & Drug Administration).  FDCA (Food, Drugs, & Cosmetics Act).

The Park Doctrine Resurrected | Marler Blog:

"In part, the focus of the Court’s opinion was whether “the manager of a corporation, as well as the corporation itself, may be prosecuted under the FDCA for the introduction of misbranded and adulterated articles into interstate commerce.” The Court concluded the answer to be yes."

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