This GMP inspections webinar will review what to expect during the agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection.
Regulatory agencies conduct product-related GMP inspections when assessing an application for marketing approval. This inspection checks if the manufacturer complies with GMP principles and practices from ICH and the local region.
Product-related inspections may also be conducted if the agency is informed or suspects a possible GMP breach. This may be triggered by a whistle blower, an inspection for other products manufactured in the facility, or inspections conducted by other regulatory authorities.GMP breach. This may be triggered by a whistle blower, an inspection for other products manufactured in the facility, or inspections conducted by other regulatory authorities.
Inspections may be announced or conducted spontaneously. This webinar will provide practical tips and advice for ensuring that all inspections are conducted in the most effective and efficient way possible, including ongoing readiness for inspections, rehearsals and preparation for successful facility inspections, and response to findings by regulatory agencies.
- Types of Inspections (for cause, pre-approval, periodic ) – API & FDF
- Notification timing
- Foreign facilities
- What to expect during inspection
- Doing a company audit as the FDA would (fall dress rehearsal)
- Making adjustments as needed/address issues/taking needed actions
- Managing the inspection
- Inspection on follow-up
- Design Engineers
- Manufacturing Departments
- Supply Chain Departments
- Technical Operations Departments
- Quality Control Departments
- Quality Assurance Departments
- Regulatory Affairs Departments