This conference is intended to help you get familiar with the FDA-compliant implementation of 21 CFR Part 11 (Part 11) requirements applicable to the FDA-regulated industry (drugs, biologics/biosimilars and medical devices including IVDs).
This session by our expert speaker, Dr. David Lim, is further intended to increase our awareness that an adequate implementation and management of part 11 and computer system validation can greatly increase patient safety by reducing the likelihood of compromising data quality and integrity including computer system validation.
FDA frequently states “failure to maintain complete data; failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data; “failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system….”
This session will address the best practices to ensure an adequate implementation of part 11 and computer system validation requirements including how to avoid 483s and warning letters concerning part 11 and computer system validation.
David will walk you through the FDA compliant practices. This conference will provide great opportunities to improve your awareness and better implement part 11 and computer system validation requirements and to avoid citations in 483s and warning letters concerning part 11 and computer system validation.
Why Should You Attend:
Some time ago, FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, now it looks more like an ongoing program with Part 11 related issues being part of most inspection. At the beginning of the initiative, FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the guidance from 2003. In the meantime, FDA officials reported key findings, and inspectors regularly cited deviations related to computer validation and other Part 11 issues. Due to lack of clear guidance from the FDA, the industry has lots of questions. Using recent warning letters as examples, this webinar will demonstrate how current Part 11 requirements will be met.
Backed by strong, informative content on the subject, attendees will enjoy the advantage of detailed instruction on the subject and addressing frequently asked industry queries on the topic as well.
For easy implementation, attendees will receive:
Areas Covered in the Webinar:
Who should attend?
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.