In FDA-regulated industries, it is imperative that firms should demonstrate FDA-compliant implementation of 21 CFR Part 11 (Part 11) requirements applicable to manufacturers for drugs, biologics/biosimilars and medical devices including IVDs.
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….”
Join this session, where expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, will help you and your firm to adequately develop and implement part 11 and Excel spreadsheet computer system validation. Adequate implementation of Excel spreadsheets for Part 11 compliance will ensure quality and integrity of GxP data and avoid FDA enforcement actions leading to 483s and warning letters.
This session will provide great opportunities to check your current practices and/or also to ensure your compliance for part 11 requirements for Excel spreadsheets of GxP data. It will help you get familiar with the 21 CFR Part 11 compliance requirements for Excel spreadsheets in straightforward and practical manner.
Who Should Attend
Ask a question 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.