Who Should Attend
This course is designed for professionals in the Pharmaceutical, Biotechnology and related industries who design, manufacture, organize or otherwise manage drug products and/or active pharmaceutical ingredients (API). It will be especially beneficial to individuals in the following areas:
• Regulatory Affairs
• Quality Assurance
• Quality Control
• Technical Services
It should also be of interest to suppliers to these industries.
If done properly, the Annual Product Review (APR) report can be a highly valued administrative tool by upper management.
The US and EU regulations will be followed by a discussion of how various large international pharmaceutical companies manage this system.
Discussions will include: what information to collect; how to use risk analysis; what metrics to use in the report; how to structure the report, when and how to issue it and proper follow up. In addition, how to convince upper management of the value of the report will be addressed.
Case studies of highly effective and poorly effective examples will be covered. This course encourages open discussions and an interactive environment.