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21 CFR Part 11 Guidance on Electronic Records and Electronic Signatures for Computer Systems Regulated by FDA

Event Details

21 CFR Part 11 Guidance on Electronic Records and Electronic Signatures for Computer Systems Regulated by FDA

Time: March 23, 2020 from 1pm to 2:30pm
Location: Online Event
Street: Online Event ,Compliance Key,364 E Main Street, Suite 1009
City/Town: Middletown
Website or Map: https://www.compliancekey.us/…
Phone: 7172088666
Event Type: webinar
Organized By: Compliance Key
Latest Activity: Mar 16, 2020

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Event Description

Topic : 21 CFR Part 11 Guidance on Electronic Records and Electronic Signatures for Computer Systems Regulated by FDA

Register: https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1575&speakerid=60&source=MTN_LN

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

Overview

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. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

Areas Covered in the Session :

  • Gain an understanding of FDA's 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidance document
  • Develop the ability to apply 21 CFR Part 11 when implementing, validating and maintaining computer systems in your organization
  • Understand the best practices for maintaining a computer system with ER/ES capability in a validated state
  • Discuss the best practices necessary to ensure all systems with ER/ES capability are validated appropriately
  • Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk, as it applies to the use of ER/ES capability

Speaker Profile :

Carolyn Troiano is Keynote Spe aker at ComplianceKey.She has more than 30 years of experience during which she worked directly, or as a consultant, for many top-tier pharmaceutical, medical device and biological companies in the US and Europe. She was responsible for computer system validation compliance activities across all GxP functions at a major pharmaceutical company. She developed computer system validation programs and strategies and was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation.

Contact Info :

Compliance Key

https://www.compliancekey.us/

Email :support@compliancekey.us

Phone : +1 717-208-8666

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