In recent years, the FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of the industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health.
These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. The underlying premise in §§ 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding safety, identity, strength, quality, and purity.
The FDA is increasingly focusing on data integrity issues, including data manipulation, when conducting facility inspections. Join this session with expert speaker Angela Bazigos, where she will review the date integrity guidance released by the FDA. She will proceed to explain the basics of data integrity covered in the guidance and will explain how to implement it at your company. The session will provide you tools to ensure you understand data integrity issues and best practices to ensure data integrity at your company.
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.
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...
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