The GMP board game that tests and improves your GMP compliance, knowledge, attitude and awareness!
GMP translations (FR, SE, DK)
Search tool and document library. Find your way in regulations, guides and other reference documents.
Pharmaceutical industry, Final dosage form
The pharmaceutical GMP regulations in 21CRF211 are written in a very general format and, therefore, must be interpreted to ensure their proper and effective application. The FDA stated that the GMP was intentionally written as such to allow the pharmaceutical industry flexibility to apply the GMP in a manner appropriate for each specific operation and pharmaceutical product. To keep pace with the rapid technological advances in the industry since the 1978 GMP rewrite, the FDA has been supplementing the GMP regulations with interpretive guides, guidelines, policy statements, and revisions to keep the regulations current, and to ensure their applicability to current industry operations and practices.
This course will focus on the FDA's current interpretations of the GMP regulations with an in-depth review of the agency's regulations, guidances, inspection guides, compliance policy guides, compliance programs, and published policy statements. Each section of the GMP regulations is reviewed along with the FDA's interpretations for that section. An integral part of this course is the intensive class work to enhance the interpretation, and the practical and effective application of the GMP requirements.
• Review of GMP Regulations, FDA Publications and Other Sources of
• Basic Techniques for GMP Interpretation
• GMP Interpretation by Subpart with FDA References
- GMP Preamble
- ICH Guidelines (where applicable)
- FDA Inspection Guides
- FDA Compliance Programs
- FDA Compliance Policy Guides
- FDA Inspection Guides
- Other FDA Publications, e.g. FDA CGMP Notes
• Review of FDA Inspectional Observations and Warning Letter Citations
• Class Exercises on Practical Application and Interpretation of GMPs
This course will provide the attendees with a practical understanding of the GMP regulations. They will become familiar with the available FDA documents and references that are essential for GMP interpretation, and the compliance and legal impact behind each of these references. The attendees will learn how to effectively use the FDA documents and references to provide an official and most precise interpretation of each GMP requirement, and interpret and apply the GMP regulations to specific operations and unique situations. This practical knowledge and understanding of the GMP regulations will provide the attendee with the skills to effectively communicate and negotiate with the FDA on GMP compliance issues.
This is an essential course for professionals who are responsible for GMP Compliance and Auditing, Quality Assurance and Regulatory Affairs. Production and support personnel, as well as those who need to interact with the FDA on GMP compliance issues, would benefit significantly from this course.
Unique Course Notes:
The Notes for this course will serve as a useful reference guide after the course. Each section of the GMP is reprinted in the course notes, followed by the interpretations for that section. Each interpretation includes the appropriate FDA reference. There is no similar reference publication available elsewhere.
Feedback from participants:
(4.8 of 5)
"Interesting lectures with an inspiring flow and very good examples."
" Compendium with interpretations a marvelous reference in my future work."
"I will have huge use of what I have learnt in my future work!"
"I cannot thank you enough for this course."
" A marvelous material"
October 30 - November 1, 2013
Specify our booking code D000030870 to get a discount when making a reservation at Scandic.
Day 1: 8.30-16.30
€ 2.295 incl. course material, lunches and refreshments
For larger groups we can offer discounts based on case by case discussions, please contact for quotation.
Cancellation policy for Compliance Seminars®:
Registration is binding and when you have received our confirmation the following conditions are know and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 200 € (Euro). Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.
Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start.) In such circumstances course fees will be refunded, or granted to attend another course for the same value.