Preparing for an FDA Pre-Approval Inspection - Webinar By ComplianceOnline (FDA Compliance Train)
Venue: Online Event
|Event Date/Time: Aug 25, 2011||End Date/Time: Aug 25, 2011|
FDA pre-approval inspections are a critical and integral part of the approval process for drugs, biologics, and medical devices.
This course is designed to teach participants about the development of this inspection program, its purpose and scope, how they are conducted, and suggest practical steps to ensure success. Regulatory consequences from inspection results will also be covered.
- History behind FDA pre-approval inspections.
- Purpose of FDA pre-approval inspections.
- Scope of FDA pre-approval inspections.
- Consequences of FDA pre-approval inspections.
- Keys to a successful FDA pre-approval inspection.