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Data Integrity - US FDA Requirements
- Data Integrity and the FDA - then and now
- Draft Guidance on Data Integrity
- FDA’s enforcement approaches
- System vulnerabilities, Cloud, updates and other concerns
- "Documented at Time of Performance"
- "Backup Data" - the uncommon meaning
- "Storage and retrieval"
- "Original records,” “true copies,” or other “accurate reproductions"
- Validation and unique documentation requirements
Overview of the webinar
Due to the growth of electronic records and electronic signatures in CGMP documentation, as well as computer-controlled manufacturing, and medical devices, the US FDA has issued a draft Guidance for Industry, outlining its expectations for increased data integrity in this changing environment. This webinar will focus on the key issues raised by the FDA, not just for products and their manufacture , but expectations for all areas of CGMP documentation and compliance in all regulated industries. Data integrity has always been at the top of the list for FDA oversight, and it continues to come under increased regulatory review. The Agency leaves the how of compliance up to the manufacturer, as long as the principles in the guidance are met in the resulting product and/or system; and on electronic-specific tools / techniques to achieve CGMP compliance. How do companies ensure accuracy and integrity of data with the steady stream of updates, upgrades, new revisions / releases, service packs, and similar that are automatically uploaded to a company’s systems, which threaten data integrity and security, and can render previous verification and validations worthless (no change control / “line drawn in the sand”, and subsequent analysis of change’s effect on existing V&V). This webinar will consider the key areas of concern for data integrity in the CGMPs, product development and manufacture, and post-production by the CAPA system, among others.
Who should attend?
- Senior management in Drugs, Devices, Combination Products, Biologics, Tissue
- QA / RA
- Software development, programming, documentation, testing teams
- R&D
- Engineering
- Production
- Operations
- Marketing
- Consultants; others tasked with product, process, electronic records software V&V responsibilities
Why should you attend?
"Data integrity is a recent concern for medical products, due to the increased reliance on electronic software, records and signatures, stand-alone or networked.
Initially there were regulations such as 21 CFR Part 11 in the U.S. and Annex 11 in Europe. But more must be done to ensure the integrity of CGMP documents / records / data. As a result, the US FDA has issued a Device Draft Guidance for Industry: “Data Integrity and Compliance With CGMP - Guidance for Industry”, 2016, and a Final Guidance for Pharma, in 2018. Regulatory agencies leave the specifics up to the manufacturer, as long as the principles in the guidance are addressed. Related data integrity issues are addressed by the CGMPs, specifically design control (21 CFR 820.30) for devices, and post-production issues by the CAPA (Corrective and Preventive Action) system, among others. The U.S. FDA has increasingly observed CGMP violations involving data integrity during CGMP compliance inspections. Adding to the problem is BYOD – “Bring Your Own Device”(laptop, tablet, smart phone, or other “smart” device) to the workplace. These growing trends pose problems to the integrity of data. The increasing use of cloud (Internet)-based software to accomplish CGMP tasks, store / retrieve data (data warehousing) and similar uses poses additional problems."
"Data integrity can be defined as “the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life cycle”. It is a critical to the storage, processing, or retrieval data.
The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended [stored] and upon later retrieval, ensure the data is the same as it was when it was originally recorded."
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.