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

March 23 @ 1:00 pm - 2:30 pm CDT

$189

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=CC_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 :[email protected]

Phone : +1 717-208-8666

Details

Date:
March 23
Time:
1:00 pm - 2:30 pm
Cost:
$189
Event Tags:
Website:
https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1575&speakerid=60&source=CC_LN

Organizer

Compliance Key
Phone:
7172088666
Email:
support@compliancekey.us
Website:
https://www.compliancekey.us/

Venue

Online Event
Compliance Key,364 E Main Street, Suite 1009
Middletown, DE 19709 United States
+ Google Map
Phone:
7172088666
Website:
https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1575&speakerid=60&source=CC_LN