In FDA-regulated industries, it is imperative that manufacturers for drugs, biologics, biosimilars and medical devices including IVDs demonstrate FDA-compliant implementation of 21 CFR Part 11 (Part 11) requirements. The FDA frequently states in their warning letters, “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….” as reasons for enforcement action.
Join expert speaker Dr. David Lim, in this session, to learn to adequately develop and implement Excel spreadsheet computer system validation in your organization in compliance with Part 11. You will get in-depth insights to improve your awareness in order to better implement Part 11 and computer system validation requirements to avoid citations in 483s and warning letters. This session will provide an opportunity for you to check your current practices and ensure compliance for Part 11 requirements for Excel spreadsheets of GxP data.
This session will help you adequately develop and implement Part 11 and Excel spreadsheet computer system validation, so you can ensure quality and integrity of GxP data and avoid FDA enforcement actions leading to 483s and warning letters.
Who Should Attend
Ask questions at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
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.