On May 5, 2011, FDA sent a Warning Letter citing a firm’s in adequate 21 CFR 11 compliance, stating: “It is your responsibility to ensure the integrity of the data generated and that all test results be properly documented, maintained, and reported.” This followed a March 30, 2011 Warning Letter wherein FDA emphasized its expectation for Part 11 compliance, saying: “Please provide a comprehensive corrective action plan that describes your commitment, procedures, actions, and controls to ensure data integrity.”

The preamble to 21 CFR 11 mentions record integrity more than 30 times. In July 2010, FDA announced a re-emphasis on inspections for electronic records integrity as part of GMP, GLP and GCP compliance, and inspectors were instructed what to when their initial findings suggest a company's electronic records may not be trustworthy and reliable.

So where do you start in ensuring your quality system and FDA compliance programs prove data integrity to FDA inspectors? How does a normal FDA inspection suddenly turn into a Part 11 investigation? In this audio conference, our speaker – a former C-level biotechnology executive who was personally trained to conduct Part 11 inspections by the authors of 21 CFR 11 – will explain current FDA Part 11 inspections, the FDA’s critical data integrity expectations, the data quality red flags that will lead to a Warning Letter, and how to ensure that your Part 11 efforts will prove data integrity to the FDA inspector.

This audio conference covers:

• The most common FDA inspector questions regarding data integrity and Part 11
• Designing Part 11 validation projects to ensure data integrity
• Steps you should take to prove record integrity throughout your quality system
• When does a regular FDA inspection become a Part 11-focused inspection under the new rules?
• Identifying and addressing weaknesses in your electronic records
• Key SOPs that must be involved in proving data integrity and Part 11 compliance
• The core components of a validation plan that prove record integrity
• How to handle outsourced IT and data centers
• To what extent should senior management be involved?

About the speaker:

John Avellanet is an internationally renowned speaker and authority on lean compliance topics related to Part 11, IT compliance, and effective records archival. He spent 15 years personally accountable for regulatory compliance and vendor oversight, most recently as a C-level executive in a combination biopharmaceutical and device Fortune 50 subsidiary. Since founding Cerulean Associates LLC in 2006, he’s traveled around the world helping clients and solving problems with practical, innovative solutions to strengthen compliance while lowering costs and reducing risk. Mr. Avellanet has been interviewed on multiple radio programs and in media podcasts, and his most recent book, Get to Market Now! Turn FDA Compliance into a Competitive Edge, was featured at BIO 2011.

Who should attend?

• Quality Assurance Directors and Managers
• Quality Assurance Professionals
• Regulatory Professionals
• IT Managers and Professionals
• Computer Validation Professionals
• Purchasing