This Laboratory GMP inspection webinar will discuss how to handle FDA inspections by identifying the red flags, the target areas and knowing the steps of inspection.
This webinar will begin with an overview of the FDA GMP Inspection process. The expectations for each of the Lab cGMP systems will be reviewed. Key target areas during regulatory inspections will be discussed. The Workshop will conclude with a discussion about how to prepare for inspections and procedures to follow during and after an inspection.
Areas Covered in the Seminar: - Purpose of an FDA inspection.
- Inspection red flags.
- Inspection Target Areas.
- Preparing for an inspection.
- Steps to follow during inspections.
- How to respond to 483s.
Who Will Benefit:This course is intended to provide training to the attendee on how to handle FDA inspections
- QC personnel
- QC Supervisors and Management
- QA personnel
- QA Management
- Documentation management specialists
- Regulatory affairs personnel
