In the FDA-regulated industry, it is imperative that firms demonstrate FDA-compliant implementation of 21 CFR Part 11; requirements applicable to manufacturers of drugs, biologics/biosimilars and medical devices including IVDs. FDA has frequently released statements on the important of meeting these requirements.
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.
Join expert speaker Dr. David Lim, in this audio session to learn to adequately develop and implement part 11 and Excel spreadsheet computer system validation in your organization. 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.
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.