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21 CFR part 11 Compliance – Electronic Records & Electronic Signatures

February 18 @ 3:30 pm - 4:30 pm CST

$179

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

Register : https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1583&speakerid=48&source=CC_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 : [email protected]

Phone : +1 717-208-8666

Details

Date:
February 18
Time:
3:30 pm - 4:30 pm
Cost:
$179
Website:
https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1583&speakerid=48&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=1583&speakerid=48&source=CC_LN