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21 CFR Part 11: Basic Concepts for FDA Regulated Companies
A comprehensive history and detailed overview of 21 CFR Part 111
- Specifics on Subpart A:
- General Provisions
- Specifics on Subpart B:
- Electronic Records
- Specifics on Subpart C:
- Electronic Signatures
Complete scope of regulations and their direct applications
Overview of the webinar
- This presentation provides an overview and historical perspective of the Part 11 regulation, the general requirements,electronic records requirements, and electronic signatures requirements
- Critical, regulated training provides compliance, improves processes, reduces negative reviews, and improves work consistency
- Provides a clear approach to understanding the history and reasoning behind electronic records and software regulation for project management personnel, its staff, operations staff and quality assurance personnel
- Clear, step-by-step guidance helps ensure strategy for delivering high-quality products at a profit with consistent operation of all systems
Who should attend?
- Project/Strategic Management
- Quality Assurance staff
- IT staff
- Operations staff
Why should you attend?
This webinar presents a clear approach to the understanding of the history and reasoning behind electronic records and software regulation. Compliance with the requirements of 21 CFR Part 11 is carefully enforced and continues to challenge the industry.
This comprehensive course provides clear guidance to project managers, IT managers and quality assurance personnel on how to formulate and deliver best practices in regards to Part 11 to their individual teams.
Faculty - Mz.Angela Bazigos
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.