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Best Practices for Managing FDA Investigators and Handling FDA 483 Observations
This course offers a unique perspective and is a succinct overview of best practices that can really help you avoid these compliance situations, described above
Description
In this course, you learn how to properly manage FDA during an inspection, how to impact the FDA decision-makers, and how to respond to FDA 483 Observations. In addition, the course will show you how to strategically address compliance issues and avoid a Warning Letter
Since FDA continues to crack down on cGMP violators and issuing 483s and Warning Letters as well as ordering shut-downs and investigations for non-compliance, the potential for millions of dollars lost is not worth the risk. If a firm proactively addresses compliance issues during and following an FDA inspection, then this preparation can save QA and Regulatory professionals manpower, time and money.
This FDA inspection best practices course offers a unique perspective and is a succinct overview of best practices that can really help you avoid these compliance situations.. In this course, you learn how to properly manage FDA during an inspection, how to impact the FDA decision-makers, and how to respond to FDA 483 Observations. In addition, the course will show you how to strategically address compliance issues and avoid a Warning Letter.
Areas Covered in the Seminar:
- Inspectional preparations and logistics.
- Manage the FDA Investigator for the best outcome.
- Influence FDA decision-makers.
- Properly accept FDA 483.
- Respond strategically to FDA 483.
- Develop a strategic Corrective Action Plan.
- Intercept and Avoid a Warning Letter.
Who Will Benefit:
- Executive Managers faced with a future FDA inspection
- Personnel with direct and indirect FDA contact prior, during, and after a FDA inspection
- Quality Assurance managers and personnel
- Regulatory Affairs and Compliance managers and personnel
Instructor Profile:
Glen Feye, M.S., CQE is the President of Accurate FDA Consultants a full service consulting firm that specializes in regulatory and clinical affairs, quality systems, training solutions and compliance for the FDA regulated industry. Mr. Feye is a senior Regulatory Affairs and Quality Assurance professional with first-hand experiences with interaction with the FDA in the medical device, IVD, biologics, and pharmaceutical industries. He has helped numerous clients prepare for successful FDA Inspections, a s well as respond properly to FDA-483. In addition, Mr. Feye has helped clients resolve over 20 Warning Letter cases.
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