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      How to Comply with 21 CFR 11 Requirements in Fremont

      • How to Comply with 21 CFR 11 Requirements Photo #1
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      May 2, 2018

      Wednesday  10:00 AM - 11:30 AM

      161 Mission Falls Lane, Suite 216,
      Fremont, California 94539

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      How to Comply with 21 CFR 11 Requirements

      In this webinar would apply to computerized systems that create source documents (electronic records) that satisfy the requirements in 21 CFR 312.62(b) and 812.

      Areas Covered in the Session:
      What are source documents and why are they important? (FDA and ICH GCP E6 Guideline)
      What are required characteristics for source documents?
      What is 21 CFR Part 11?
      How can you apply 21 CFR 11 and ICH E6 to source documents?
      How EMR Data is used in Clinical investigations
      How to plan electronic source document deficiencies

      Who Will Benefit:Investigators
      Clinical Research Coordinators
      Device and Drug Study Clinical Research Associates
      Clinical Research Associate Managers
      Project Managers
      Quality Assurance Personnel
      Regulatory Affairs Personnel

      Speaker Profile:
      Angela Bazigos Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development.

      Event Fee: One Dial-in One Attendee Price: US$150.00

      Contact Detail:
      Compliance4All DBA NetZealous,
      Phone: +1-800-447-9407

      Cost: Payment required - One Dial-in One Attendee Price: $150.00

      Categories: Conferences & Tradeshows | Education | Health & Wellness

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.