It used to be that all controlled documents were stored as hard copy in a document center where they would be signed out for presentation to inspectors. These days, records are stored in a variety of computerized systems. They are typically printed out in the last minute and with minimum review. When these records are then made available to inspectors, they are often incomplete and inaccurate.

In this audio conference, our speaker provides an understanding of official records, explores different strategies, and explains how to prepare your records for an FDA inspection in a more complete and accurate manner.

This audio conference covers:

• How to prepare for an FDA inspection
• Front room strategies
• Back room strategies
• How to cope with different types of electronic documents
• The importance of performing a mock audit before inspection

About the speaker:

Ron Eisenwinter is a regulatory and quality consultant with over 35 years of software experience, 10 years of experience in the medical device industry, and 15 years of experience consulting for the drug, biologics and medical device industries. He has performed numerous quality system audits for major corporations, has guided many companies through FDA inspections, and has also advised companies on 21 CFR Part 11 via a risk-based approach. Through software validations, process validations, clinical trials and regulatory submissions, Ron has worked with a wide variety of computerized systems. He is currently affiliated with MedTec Associates, Software CPR, and Barile & Associates.

Who should attend?

• Regulatory Affairs
• Quality Assurance
• Document Control
• IT/Computerized System Managers
• Production Staff