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Subscribe NewsletterAvoid Warning Letters in View of the U.S. FDA’s Stated Goal to Increase Their Use
Product Id
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600049
Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
Targeted cGMP issues. How can a company proactively minimize the chance of receiving a Warning Letter? Areas a company "must review" beforehand. What to doing during an FDA compliance audit. What to do immediately after the audit. What to do during the response period. Lessons learned.
Targeted cGMP issues. How can a company proactively minimize the chance of receiving a Warning Letter? Areas a company "must review" beforehand. What to doing during an FDA compliance audit. What to do immediately after the audit. What to do during the response period. Lessons learned.
Areas Covered in the Session:
- The U.S. FDA’s new aggressive implementation plans
- Proactive reviews of the applicable U.S. FDA / cGMP requirements
- Key areas to focus limited resources
- FDA Inspectional Objectives
- Common areas for critical mistakes
- Recent trends and events
- The compliance audit
- Q&A
Who Will Benefit:
- Senior management, project leaders
- Regulatory affairs
- Quality systems personnel
- Internal and supplier auditor personnel
- R&D and engineering staff
- CAPA and P&PC personnel desiring to optimize systems and responses in harmony with the U.S. FDA’s quality management systems / cGMP expectations.