Mastering FDA inspections: Preparation and Best Practices - Efficient and effective preparation strategies - Webinar von FORUM Institut für Management GmbH

- Key regulatory requirements - How to prepare in advance? - Special considerations in FDA inspections - Follow-up: What you need to pay attention to - Avoiding FDA 483s, handling warning lettersFDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and ease.

Your desire for the next FDA inspection: The list of deficiencies remains small because your company is inspection-ready prior to it?!- This seminar aims to provide you with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical facilities. It will also cover the FDA’s approach to inspections, focus areas, and the documents they will be asking for.- By the end of the seminar, you will have learned how to manage inspections efficiently and effectively, and how to present information about your quality system in the most competent and professional manner.

This seminar suits the needs of pharmaceutical industry professionals, who have to deal with the preparation and management of an FDA inspection.- In particular, participation will benefit: - Managers of Regulatory Affairs and Quality Assurance; as well as - Regulatory Affairs professionals that submit INDs, NDAs, BLAs, and ANDAs.