This FDA Inspection will discuss FDA inspection readiness techniques and how to prepare your organization for a facility inspection.
Areas Covered in the seminar:
- FDA authority to inspect (domestic and foreign)
- How FDA prioritizes which firms are inspected
- FDA Risk based approach and QSIT
- Types of FDA inspections
- Confidentiality of records
- What records will be reviewed
- Who participates during the inspection and what are their roles
Who Will Benefit:
- Senior Management
- Quality & Regulatory professionals
- Operations and Engineering personnel
Course Provider
Sue Jacobs,
