Data Integrity - US FDA Requirements

John E Lincoln
John E Lincoln
90 Minutes
Product Id:
6 months

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$190 Recorded
$390 Corporate Recorded
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Due to the growth of electronic records and electeronic 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in CGMP documentation, as well as computer-controlled manufacturing, and medical devices, the US FDA has issued a draft Guidance for Industry, outlining its expectations for increased data integrity in this changing environment.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 producs and their manufactue , 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 guidances 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.

Why you should 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 As a result, the US FDA issued a Draft Guidance for Industry: "Data Integrity and Compliance With CGMP - Guidance for Industry", 2016. 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.

Areas Covered in the Session:

  • 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

Who Will Benefit:
  • 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

Speaker Profile
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

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