Overview: This interactive webinar begins with an overview of the FDA Inspection process.
Preparation for the inspection in the months before, the immediate weeks before and on the day of the inspection will be discussed. The Inspection process will be reviewed followed by a detailed look at common focus area areas of Inspectors. Procedures to be followed after the inspection such as preparation of the response to 483s will be discussed. Ample discussion time will be available at the halfway point in the webinar and again at the end of the webinar.
Why you should attend: Pre-approval inspections provides a relatively narrow window of time during which the NDA/BLA/ANDA holder can demonstrate to the FDA that the quality systems at the site are in compliance with the GMPs and that appropriate facilities are available to support manufacture of the product. It is therefore important to present the organization in the best light possible.
Areas Covered In the Seminar: - Pre-Approval Inspections
- Overview of the pre-approval inspection process
- Preparation in the months preceding the inspection
- Preparation on the day of the inspection
- What to expect on inspection day
- Responding to 483
Who will benefit: This course is intended to provide training how to prepare for FDA Pre-approval inspections.
- QC Supervisors and Management
- QA personnel
- QA Management
- Documentation management specialists
- Regulatory affairs personnel
