Learn valuable insights and strategies from industry experts.
Using electronic records and signatures (ER/ES) under 21 CFR Part 11 brings specific controls: removing print capability so decisions rest on the electronic record, verifying that the signer is the person whose credentials are entered, enforcing password rules, and stating exactly what each signature means, such as performed, recorded, reviewed or approved.
This 60-minute 21 CFR Part 11 compliance training covers how to validate systems and keep them validated throughout their life cycle. You'll learn how the SDLC supports computer system validation, how to document it, and the policies and procedures a company needs to interpret its Part 11 responsibilities.
The session also looks at industry best practices, FDA inspection trends and ways to reduce the cost of compliance.
Compliant computer system validation is critical for any FDA-regulated organization, but the volume of guidance can be overwhelming. This session condenses it to the methods, techniques and tools that give the best results at sensible cost.
It suits anyone who plans, runs, maintains or supports an FDA-regulated system with ER/ES capability, including IT, QA/QC, validation, laboratory, manufacturing, clinical data and regulatory staff.
Anyone who is involved in the development, testing, manufacturing, storage, handling, and distribution of products must understand and conform to FDA requirements for data quality and integrity.
Finally, anyone who is developing and maintaining software used in these industries should be aware of the requirements for data integrity for their systems.
Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
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