"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
CGMP: Interpretation and Application
Pharmaceutical GMP requirements, as specified in 21CFR211, are general and subject to interpretation. The FDA stated that the GMP was intentionally written as such to allow the pharmaceutical industry the flexibility to apply the GMP in a manner appropriate for each specific operation.
To keep pace with the rapid technological advances in the industry since the 1978 GMP revision, the FDA has been supplementing the GMP with interpretive guides, guidelines and policy statements to keep it current and to ensure its applicability to current industry operations and practices.
This course will focus on the FDA's current interpretation of the GMP regulation with an in-depth review of the agency's regulations, guidances, inspection guides, compliance policy guides, compliance programs, proposed rules, publications and policy statements. Each section of the GMP regulations is reviewed along with the FDA's interpretations of that section. An integral part of this course is the intensive class work to enhance the interpretation and practical application of the GMP requirements.
- Review of GMP Regulations, FDA Publications and Other Sources of GMP Interpretations
- 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 be 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 interpretation of GMP requirements, and interpret and apply 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.
Who should attend:
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 binder 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.
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »
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Pharmaceuticals, Final dosage form
Intermediate / Advanced
Mr. John Y. Lee
Next occation during 2018
Date and location to be confirmed.
8.30-16.30 (Registration 08.00-08.30, day 1)
22 400 SEK (€ 2 395) incl. course material (pdf), lunches and refreshments
Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.
For groups registered and invoiced together we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
We do not offer or practice any general company discounts without commitments and/or written agreements.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
* If you still want a printed course handouts binder from us, we charge 50 Euro/pcs (of which 10 Euro to TRINE for clean energy projects)
Cancellation of registration:
Registration is binding and when you have received our confirmation the following conditions are known 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 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.
Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.