NOTICE: Many events listed here have been canceled or postponed due to the Covid-19 emergency. It is best to call ahead or check with organizer's websites to verify the status of any local event.

Change Location × Middletown, DE

    Recent Locations

      21 CFR part 11 Compliance - Electronic Records & Electronic Signatures in Middletown


      • 21 CFR part 11 Compliance - Electronic Records & Electronic Signatures Photo #1
      1 of 1
      February 18, 2020

      Tuesday   3:30 PM - 4:30 PM

      Compliance Key,364 E Main Street, Suite 1009
      Middletown, Delaware 19709

      Map
      Performers:
      • No Performers Listed
      EVENT DETAILS
      21 CFR part 11 Compliance - Electronic Records & Electronic Signatures

      Topic : 21 CFR part 11 Compliance - Electronic Records & Electronic Signatures

      Register : https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1583&speakerid=48&source=EF_LN

      Discount Coupon : Use this Coupon (NEW2COMPLIANCE) and get (10% Off) On New Signup

      Overview

      This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.

      Areas Covered in the Session :

      Origin of the regulation and changes in interpretation
      Electronic records
      Electronic signatures
      Data security
      Open, closed and hybrid systems
      Validation methods
      Risk analysis

      Speaker Profile :

      Ed is Keynote Speaker at ComplianceKey. He is retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing. He now consults internationally in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.


      Contact Info :

      Compliance Key

      https://www.compliancekey.us/

      Email : support@compliancekey.us

      Phone : +1 717-208-8666

      Cost: Payment required - Single Attendee: [Only for one participant] $179 (Live) $275 (Live + Recorded) Multiple Attendee: [For a group of 2-5 participants] $368 (Live) $649 (Live + Recorded)

      Categories: Conferences & Tradeshows | Education | Business & Networking

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