How to Prepare for FDA GMP Inspections
Instructor:
James Harris(PhD)
Product ID: 700990
- Duration: 60 Min
Only some GMP inspections (such as Pre-approval inspections) come with enough advance warning for us to be prepared. However, most such inspections come completely by surprise. Because of this, a system for hosting an inspection team and monitoring its activities must be established in advance of an inspection.
This program outlines a system for preparing for an unexpected inspection and details SOPs that should be established in advance of the appearance of the inspectors. In addition, key inspection topics that are the current "hot buttons" for the FDA will be reviewed; and approaches that will keep these points off your FD 483 will be identified.
Areas Covered in the seminar:
- Identifying and training an inspection host team.
- Rules to know and follow.
- What to do when an FDA inspection team arrives.
- How to manage a typical inspection.
- Typical Points of FDA Interest.
- The exit interview.
- The FD 483.
- Actions needed following the Fd 483.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that face unscheduled inspections by regulatory agencies. The program is specifically intended for companies that manufacture medical devices, diagnostics, pharmaceutical, and biologics products. Employees that will benefit include:
- Quality control
- Quality Assurance
- Manufacturing
- Technical service
- Managers
- Supervisors
- Employees that could come into contact with inspection personnel.
James R. Harris, PhD held VP level management positions in several of the world’s largest pharmaceutical firms before forming a consulting organization that worked globally serving pharmaceutical and related industries in over 60 countries.
Related Information: FDA GXP Compliance
The FDA initiatives "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach" concerns the regulation of pharmaceutical manufacturing and product quality with an aim to focus GMP enforcement on high-risk products.
Read More on
FDA GXP Compliance
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