Product Details
During a regulatory inspection, having quick and easy access to your most important documentation is essential for a positive outcome. With the FDA now looking at records electronically — either on site or remotely — the necessity of always being “inspection ready” has increased exponentially.
To increase your expertise on effective data and documentation processes, turn to this must-read report Managing Data and Documentation for FDA Inspections and Remote Assessments. With practical advice and insights from current and former FDA inspectors, you’ll learn how to optimize and organize your records for your next inspection while avoiding pitfalls in data retrieval, improper or missing documentation and electronic data transmission.
Key Takeaways:
- Understand the types of documents commonly requested during inspections and remote assessments.
- Handle paper documents properly and provide investigators with access to electronic source data without compromising security.
- Determine the “Top 10” questions to ask about your archival process.
- Know the perils of emails as documentation and how to avoid them.
- Recognize the difference between copies and originals and what FDA regulations require.
Arm yourself with the knowledge needed to ensure a successful FDA inspection or record review. Order Managing Data and Documentation for FDA Inspections and Remote Assessments today.
About the Contributors
David Chesney is the Principal and General Manager for DL Chesney Consulting, providing GMP and GCP compliance consulting and training services to clients worldwide. He served for more than 20 years as vice president, strategic compliance services for PAREXEL Consulting. Prior to joining PAREXEL, he served 23 years with the FDA as an investigator, supervisory investigator, Director of Investigations and as District Director in San Francisco, managing all FDA operations in Northern California, Nevada, and Hawaii.
This report also includes insights from Elizabeth Miller, FDA Assistant Commissioner for Medical Products and Tobacco Operations, and two former FDA investigators — Robert Darius, head of quality compliance at Sanofi Specialty Care, and William Mestrandrea, senior director of GMP/GDP auditing and inspection preparedness at Bristol Myers Squibb.
Who Will Benefit
- QA/QC managers and staff
- Document managers and staff
- Regulatory affairs managers and staff
- IT managers and staff
- Lab managers and staff
- Project coordinators
- Principal investigators
Add to Cart
Contributors:
David Chesney, Elizabeth Miller, Robert Darius and William Mestrandrea
ISBN:
978-1-60430-220-2
Publication date:
Sept. 2023
Page count:
66
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