The FDA Audit inspection training defines the laboratory environment; points out problem areas and common pitfalls; and details solutions and also details how to prepare the Laboratory staff for an Inspection as well.
Quality Control Laboratories continue to be a focal point of US FDA inspections and Compliance Audits. This program will focus on the principles and application of the FDA GMP regulations as they apply to the operation and management of today's pharmaceutical QC laboratory. The program defines the laboratory environment; points out problem areas and common pitfalls; and details solutions. The program also details how to prepare the Laboratory staff for an Inspection as well.
Quality Control Laboratories continue to be a focal point of US FDA inspections and Compliance Audits. This program will focus on the principles and application of the FDA GMP regulations as they apply to the operation and management of today's pharmaceutical QC laboratory. The program defines the laboratory environment; points out problem areas and common pitfalls; and details solutions. The program also details how to prepare the Laboratory staff for an Inspection as well.
Areas Covered in the seminar:
- Regulatory requirements applicable to the QC Laboratory.
- Areas to Troubleshoot.
- Preparing for the Inspection-Facility & Staff.
- Hosting the Inspection.
- Inspection Do's & Don’t's.
- Concluding the Inspection.
Who Will Benefit:
- This webinar will provide direction to all regulated companies that need to utilize the principles of GMP compliance for improved laboratory performance and overall compliance
- Managers
- Supervisors and Associates in the Pharamceutical Industry that have daily responsibilities in Quality Assurance
- Quality Control and Compliance
Course Provider
Michelle Sceppa,
