How to Audit API Manufacturers
Venue: The Window Conference Centre
|Event Date/Time: Nov 13, 2008||End Date/Time: Nov 13, 2008|
|Registration Date: Nov 06, 2008|
|Early Registration Date: Aug 22, 2008|
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.
QPs are required to declare that the active materials used in each of their products have been manufactured to GMP as interpreted by the EU.
Participants will learn about the legislatorsâ€™ 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.
Who should attend
Supplier auditors for drug products manufacturers
QPs in manufacture of drug products
QA managers who support the QP / declaration
QC managers of drug products manufacturers
Production managers of drug products manufacturers