This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe. It will also discuss the comparative evaluation about similarities and differences of requirements associated with the manufacturing of the drug product in different countries. It is also necessary to know that the regulatory requirements of different countries are different and hence this will further guarantee the quality of the pharmaceutical product.
Agenda
,What needs to be included in the report,A model of an example Annual Product Review Report,Review of citationsWho Should Attend
- QA staff and management
- Compliance Personnel
- Regulatory Affairs staff and management