Electronic Records & Electronic Signatures, 21 CFR Part 11, Basic Concepts - Recorded Webinar

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Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Angela Bazigos

OVERVIEW:
This presentation will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements,electronic records requirements, and electronic signatures requirements.

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.

Areas Covered in the Session:
- 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
- IT Staff
- Operations Staff
- Quality Assurance Staff

SPEAKER PROFILE:
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashxPatent on speeding up software compliancehttps://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroomhttp://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ includes training for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.

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