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21 CFR part 11 Compliance - Electronic Records & Electronic Signatures

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

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

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


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
Email : support@compliancekey.us
Phone : +1 717-208-8666

URL: https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1583&speakerid=48&source=TM_LN
Date: Tuesday, February 18, 2020
Time: 3:30pm-4:30pm UTC
Duration: 1 hour
Access: Public
Category: Business*, IT*, Webinar*
Created by: Public Access
Updated: Wednesday, February 5, 2020 7:40am UTC
Cost ($): $179
Call In Number: 7172088666
Contact Email: support@compliancekey.us
Contact Person: Compliance
Contact Phone: 7172088666
Comments: None