21 CFR Part 11 Guidance for Electronic Records - 2018


      Originalpreis in USD:
      $ 150

      Wichtige informationen

      Tipologie Training
      Niveau Advanced
      Methodologie Online
      Unterrichtsstunden 2h
      Dauer 1 Day
      Beginn nach Wahl
      Virtueller Unterricht Ja
      • Training
      • Advanced
      • Online
      • 2h
      • Dauer:
        1 Day
      • Beginn:
        nach Wahl
      • Virtueller Unterricht

      A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability.

      Einrichtungen (1)
      Wo und wann
      Beginn Lage
      nach Wahl
      Beginn nach Wahl

      Was lernen Sie in diesem Kurs?

      Health Management
      Medical Ethics
      Education Studies
      Medical Trials
      Medical training
      Education Management
      Education and training
      Training evaluation


      Overview:This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
      Why should you Attend:This webinar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.
      Areas Covered in the Session:System Risk AssessmentGAMP 5 "V"Model21 CFR Part 11Electronic Records/Electronic Signatures (ER/ES)Security, Access, Change Control and Audit TrailPolicies and Procedures
      Who Will Benefit:Information Technology (IT) AnalystsIT DevelopersIT Support StaffQC/QA Managers and Analysts
      Speaker Profile:Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
      Event Fee: One Dial-in One Attendee Price: US$150.00
      Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email:

      Zusätzliche Informationen