22 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

  • 2023
  • Webinar

Description

22 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries is a webinar that covers topics such as:

  • System Development Life Cycle (SDLC) Methodology
  • Computer System Validation (CSV)
  • Validation Strategy
  • Good "Variable"Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • GAMP 5 "V"Model
  • System Risk Assessment
  • Electronic Records/Electronic Signatures (ER/ES)
  • 21 CFR Part 11
  • Policies and Procedures
  • Security, Access, Change Control and Audit Trail
  • Industry Best Practices and Common Pitfalls
  • Training and Organizational Change Management

22 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries is intended for:

  • IT Developers
  • Information Technology (IT) Analysts
  • QC/QA Managers and Analysts
  • IT Support Staff
  • Compliance Managers and Auditors
  • Clinical Data Managers and Scientists
  • Computer System Validation Specialists
  • Lab Managers and Analysts
  • Business Stakeholders using Computer Systems regulated by FDA
  • GMP Training Specialists
  • Consultants in the Life Sciences and Tobacco Industries
  • Regulatory Affairs Personnel
  • College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements
  • Interns working at the companies listed above

Past Events

Important

Please, check "CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Industry: Chemical
Science: Life Sciences & Biology
Technology: Biotechnology

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