Electronic records and signatures

Electronic records and signatures

Details

  • Start date: 09 March 2023
  • Start time: 10:00 (Kyiv)
  • Finish date: 09 March 2023
  • Finish time: 14:00 (Kyiv)
  • Duration: 4 hours
  • Break: yes
  • Category: Production (GMP)
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: Русский
  • Target audience: department heads, engineers, quality assurance managers, quality engineers, software developers, IT administrators/specialists.

     

    Questions will be considered:

    • Types of records

    • Overview of CFR 21 Part 11 Subpart A: General

    • Overview of CFR 21 Part 11 Subpart B: Electronic Records

    • Types of electronic records: static, dynamic

    • Data storage methods

    • Physical location of electronic records, requirements for it

    • Cloud technologies for storing GxP electronic records

    • Work with electronic records

    • Damage to electronic records

    • Copies of records

    • Deleting records

    • Overview of CFR 21 Part 11 Subpart C: Electronic Signatures

    • Use of electronic signatures

    • Validation of systems that comply with CFR 21 Part 11

    • Audit trail requirements

    • Outdated computerized systems

    • Expectation of inspectors from electronic records and signatures

    • Risks of non-compliance with CFR 21 Part 11