Complying with 21 CFR 11 for Electronic Records/Electronic Signatures
Don Hurd has over 35 years of experience in supporting the development of applications of or containing software in regulated industries, the last 17 in medical devices. With his diverse background, Mr. Hurd provides a unique insight into driving product quality and ensuring high productivity of development organizations. Mr. Hurd is currently the Vice President of Quality and Validation Services for The Realtime Group, a contract R&D firm specialized in serving the regulated industries, primarily medical devices. In this role, Mr. Hurd led the company to certification in both ISO 9001 and ISO 13485, maintaining certification for nearly 15 years. In his role at Realtime, Mr. Hurd supports clients in efforts ranging from Quality Management System development, deployment, and remediation; product and development quality planning; verification and validation of products, product software, and non-product software; supplier qualification, approval, and management; transitioning product from development to manufacturing; supporting post-market vigilance/surveillance, and interfacing with ISO auditors and FDA inspectors. Mr. Hurd has been an ASQ Certified Quality Auditor since 2009. Mr. Hurd is active in the ASQ Biomedical Division Discussion Group, ASQ Audit Special Interest Group, and bionorthTX, holding leadership positions in each.
21 CFR Part 11 was promulgated in 1979 to address a gaping hole in the regulations regarding the use of electronic records and electronic signatures. The rule was, by FDA’s admission later, confusing and challenging.
Learning Objectives
- Overview of 21 CFR Part 11
- Explain the concepts and rationale behind the rules
- Discuss the practical application of the rule
- Consider challenges with the rule
Who Should Attend
- Development Engineers
- Project Managers
- Management
- Document Control Specialists
Why Should You Attend
There is, throughout industry, considerable “Fear, Uncertainty, and Doubt” regarding Part 11. Companies are holding on tightly to their hardcopy systems due to this fear. This leads to inefficiencies and, often, documentation control failures. There are practical and logical reasons behind the regulation that, if understood and followed, can readily be applied and will strengthen your overall data integrity program.
Course Outline:
- Definitions
- Requirements review
- Scope of application
- Application with legacy systems
- Record retention
- Validation
- Electronic signatures
-
$199.00
-
