This webinar will discuss the Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation requirements, system security protocols, rules for building computer networks, adding new components to network, back-up of data, access control, rules for passwords, and audit trails. Case studies will be used to highlight common issues and potential solutions.
21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides the basic framework for computer systems used to generate records and data used for analysis and presentation. However, for any organization trying to understand and implement Part 11 requirements, there are only two options: One, hire expensive consultants and purchase expensive software, or implement self-created systems and live in constant fear of findings of non-compliance during FDA audits. In this seminar, we will simplify the regulatory requirements and add practical tips for quick and easy verification of compliance with FDA requirements which can be self-implemented by most organizations with minimum technical expertise
Areas Covered in the Session :
- Part 11 requirements by FDA
- Applicable systems per the FDA
- Validation of computer systems
- Network set-up, maintenance, integrity check and security
- Common elements of Part 11 complaint computer systems
- Building Part 11 compliant systems bottom-up and top-down.
- Back-up and re-creating data
- Verifiable audit trails
- Electronic signatures and certificates
- Best practices for using non-networked computers
Who Should Attend:
- This webinar will provide valuable information to:
- FDA-regulated labs, clinical trial sites, manufacturers, and sponsors
- Everyone involved in computer system validation
- Anyone selecting computer systems intended for FDA regulated environments
- Information technology professionals responsible for files or network locations
- Quality professionals who organize, document and verify system compliance
- Executives evaluating requirements Part 11 compliant systems
Course Director: ANGELA BAZIGOS
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,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 Patent on speeding up software compliance.
Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom 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.