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Development and Manufacture of Effervescent Tablets
Thermal Methods and Calorimetry - applications and practical help
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How to Audit API Manufacturers
| Type | Training - Paid |
|---|---|
| Language | English |
| Date |
November 9, 2011 from 08:30 am to 05:00 pm |
| Venue |
Window Conference Venue 13 Windsor Street Islington, London N1 8QG GB |
| Chemistry Specialties |
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| Chemistry Techniques |
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| Contact |
Judy Callanan PharmaTraining Limited BioCity, Pennyfoot Street Nottingham, NG1 1GF GB 44 (0) 115 9124249 44 (0) 207 6813582 judy@pharma-training-courses.com |
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This one day seminar is aimed at QA staff in drug products manufacturers and especially their QPs who have specific responsibilities under directive 2004/27/EC. Participants will learn about the legislators’ perspectives and the key differences between APIs and products, which lead to different audit techniques and thought processes when auditing API manufacturers. The seminar includes: the background to current GMPs for APIs , FDA and EU interpretation of GMPs for APIs , specific opportunities from the guidelines that API manufacturers may exploit , specifics of what to look for when auditing an API site.
Speakers
DR DAVID INGLIS is a consultant specialising in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry.