FDA and other regulatory inspections are an inevitable part of working within the pharmaceutical industry. FDA inspections can be very resource and time intensive and, if an organization is not prepared, the FDA inspection can lead to serious consequences for an organization. This webinar will discuss strategies for preparing and managing an FDA regulatory inspection at your facility. The webinar will focus on planning, preparation, and training of personnel that may be involved in hosting or supporting an FDA inspection.
Part I – Planning for a Regulatory Inspection
Part 2 – Hosting the FDA Inspection
Part 3 – The Inspection
Part 4 – The Close Out and Responses to FDA-483s
Top Reasons to Attend:
Personnel in the Following Environments Should Attend: