This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.
Why Should You Attend:
There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance inspections (audits). These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.
And business continues to "shoot itself in the foot", including once highly respected companies. All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their work for them. Failure to anticipate, find and correct compliance problems before an FDA site inspection can result in unnecessary 483 Observations, possible Warning Letters, or worst, and a competitive “hit” in the marketplace – all preventable by the effective internal CGMP compliance audit / inspection.
Areas Covered in the Webinar:
- Basic U.S. FDA's expectations – the CGMPs
- The "target" -- Tougher FDA Expectations / Requirements
- Avoid complacency from past "good" FDA / Notified Body / ISO audits
- Key medical device and pharmaceutical CGMP concerns
- A risk-based phased approach
- FDA “model” CGMP inspections
- Prove / maintain 'in control'
- Fight “entropy”
Frequently Asked Questions:
- What does the FDA look for in terms of "rework" and "reprocess". When does these terms apply; especially for labeling and packaging?
- What are the common FDA findings for Device History Records?
- What is the common inspection plan and recommended frequency for a virtual company?
- What is the expectation for virtual companies on how they should manage vendor quality systems?
Who Will Benefit:
- Senior and middle management.
- Quality Assurance
- Regulatory Affairs
- R&D
- Engineering
- Staff and Line personnel
- Sales and Marketing
- Operations / Production
