FDA’s New Draft Guidance on Data Integrity for cGMP Compliance

The U.S. FDA released the new Draft Guidance on “Data Integrity and Compliance with cGMP”. There remains some confusion as to the FDA’s current thinking with respect to electronic records and/or electronic signatures and their interpretation of 21 CFR Part 11.

Do you know what does the FDA currently expects in view of its stated narrow scope and application of Part 11, pending FDA’s re-examination of part 11 as it applies to all FDA-regulated products?

This webinar will examine related cGMP data integrity issues as discussed in the just released Draft Guidance, addressing primarily Drugs, Biologics and Veterinary, but revealing the Agency’s thinking on this subject in general.

Areas Covered in the Session : 

• Key data terms and the FDA’s definitions
• Recognize Data that must be retained and what may be excluded from decision making
• V&V requirements for data
• Come to terms with control of software, hardware, personnel and documentation
• FDA’s Current Narrow Scope and Application of 21 CFR Part 11 (ER and ES)
• FDA expectations for a Company’s Data Integrity Assurance Systems – Access, e-records / e-signatures
• Restricted access / log-ins, blank forms controls, Audit Trails, ERES
• Overview of the Data Integrity Draft Guidance
• What is cGMP Data?  Company Usage?
• Lab Data Issues
• Treatment of altered records
• FDA inspections and Potential Problem Areas and their Resolution

Who Should Attend:

This webinar will provide valuable assistance to all regulated companies and personnel in the Medical Devices, Pharmaceutical, Diagnostic, Biologics, Combination products, Dietary Supplements, and Veterinary fields. The employees who will benefit include:

• Senior management
• Middle management
• QA/RA
• Engineering
• Software
• Research & Development
• Production
• Operations
• Consultants; others tasked with product, process, validations, cGMP responsibilities

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 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 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 published 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.