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The Certified Pharmaceutical GMP Professional understands the GMP principles as regulated and guided by national and international agencies for the pharmaceutical industry. This covers finished human and veterinary drugs and biologics, ectoparasitacides, and dietary supplements (alternatively called nutraceuticals where regulated as drug products, as well as their component raw materials (includes active pharmaceutical ingredients (APIs) and excipients), and packaging, and labeling operations
Course Description: The Certified Pharmaceutical GMP Professional (CPGP) certification is a new ASQ certification intended for the experiencedpharmaceutical GMP professional and includes a global GMP body of knowledge (BOK). The BOK cites 94 source documents as references (see http://www.asq.org/certification/pharmaceutical-gmp/references.html). There is no one book or primer that covers this material and there are no published study questions that can be printed for use in class. So this course is a Facilitated Study Group and is different than most other “refresher” courses in the following ways:
- The objective of this study group is to familiarize you with and to enable you to rapidly navigate through the key source documents to find or confirm your answers during the actual examination. The class facilitators will guide you through the key documents.
- You must print off the internet and read the assigned source documents before each class. In the case of copyrighted documents, you will be provided with non-copyrighted summaries.
- You are expected to actively participate in this class. If you are a subject matter expert in a topic, you may be asked to assist in leading the discussion of that topic. Other outside subject matter experts may also be invited.
- A Class Syllabus will be provided at the first class and revised as needed based upon the background and experience of the study group members and the availability of subject matter experts.
- If you are not an experienced pharmaceutical GMP professional, this course may expand your knowledge of Pharmaceutical GMPs, You are very welcome to take this course even if you don’t plan to take the exam. If you are already certified, this course will earn you 3.6Recertification Units that may be applicable to your other ASQ recertifications.
General Course Information:
- Class starts at 6:00 p.m. SHARP and will usually end by 9 p.m. and includes one break (vending machines are available on site) unless indicated otherwise.
- There is no textbook for this course - see above for details.
- Payment for course must be made before the course start date.
- Contact information for any additional questions is provided on the registration form .
Call ASQ National at 1-800-248-1946 or go to ASQ Headquarters Website to apply for the exam. Exam registration and fees are separate from Princeton Section Course registration. You are very welcome to take this course even if you don’t plan to take the exam. If you are already certified, this course will earn you 3.6 Recertification Units that may be applicable to your other ASQ recertifications.
When & Where
Imclone
33 Imclone Dr
Branchburg,
NEW JERSEY 08876-3903
Tuesday, March 6, 2012 at 6:00 PM (ET)
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