Electronic Records & Electronic Signatures; 21 CFR Part 11

Why Should You Attend:

Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation. Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in efficiency - both efficiency in project management, and avoidance of non-compliance penalties.

This 90-minute session will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements, electronic records requirements, and electronic signatures requirements.

Areas Covered in the Seminar:

• History and Overview.
• Subpart A: General Provisions.
• Subpart B: Electronic Records.
• Subpart C: Electronic Signatures.
• Scope & Application Guidance.
• Questions and Answers.

Who Will Benefit:

• Project/Strategic Management
• Quality Assurance staff
• IT staff
• Operations staff
• For FDA regulated companies, any staff members who may be involved with –
• Computerized system projects
• Validation of those systems, or
• have responsibility for maintenance/security of electronic records.
• Additionally, staff members from companies which may develop software or computer systems for FDA regulated companies.

Instructor Profile:

Harry Huss, has over 30 years of experience in the pharmaceutical/medical industry. He is currently Chief Compliance Officer, Touchstone Technologies Silicon Valley; and has held positions as Executive Directive, Brandywine Compliance Consulting; Senior Director Compliance Policy & Program Support Services, Charles River Laboratories; Associate Director of Computer Validation Quality Assurance, Merck & Company; and Regulatory Compliance Manager, SmithKline Beecham. Harry has a M.S. degree in Clinical Microbiology from Thomas Jefferson University, and B.S. degrees in Biology and Medical Technology from Millersville University and Bryn Mawr respectively. He has provided numerous computer validation and Part 11 presentations at professional meetings, provided computer validation training for the FDA, authored a Master Validation Plan for the FDA National Center for Toxicological Research (NCTR), and published a variety of scientific and regulatory compliance articles. Harry is a member of the Drug Information Association Validation SIAC Core Committee and a member of the Society for Quality Assurance Computer Validation Initiatives Committee (CVIC).

Topic Background:

With the emerging utilization of computerized technologies in the late 1980s and early 1990s, the pharmaceutical industry asked the FDA for guidance regarding compliance of the resulting electronic records. After several years of development and industry comments, 21 CFR Part 11, the Electronic Records & Electronic Signatures Rule became law in 1997. Interestingly, as time passed other international regulatory agencies adopted similar e-records/e-signature regulations. Today, more than 15 years after introduction, compliance with the requirements of Part 11 (as the regulation is now commonly referred to) continues to challenge the industry. As with any regulation, understanding the basic requirements is key to achieving compliance.

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