Cathy Burgess presented during this webinar sponsored by Thompson Interactive. With a new Administration, and a new FDA Commissioner, inspections are almost certain to increase. And with the enforcement powers granted under FDAAA, being prepared for an inspection is now more important than ever. Those firms that have a good understanding of its compliance profile, with staff properly trained, is more likely to have a successful inspection than a firm that is unprepared. This 90-minute audio conference, compliance attorney and expert Cathy Burgess discussed what it takes to pass an FDA inspection, both in terms of meeting FDA regulations, and in management of the inspection process itself. The following topics were covered during the presentation.
- How to assess the firm's compliance profile.
- Developing a comprehensive inspection management SOP.
- How to prepare employees.
- Developing a team approach to inspection management.
- How to ensure that Senior Management is engaged.
- Do's and don'ts for interacting with investigators, including accepting and responding to observations.