Compliance for Electronic Records and Signatures (21 CFR Part 11)

Overview:
Learn exactly what is needed to be compliant for all three primary

areas: SOPs for the IT infrastructure, industry standards for software

product features, and the 10-step risk-based validation approach.

This webinar demystifies Part 11, and get you on the right track for

using electronic records and signatures to greatly increase

productivity.

Areas Covered in the Session:
Which data and systems are subject to Part 11
What Part 11 means to you, not just what it says in the regulation
Avoid 483 and Warning Letters
Explore the three primary areas of Part 11 compliance: SOPs,

software product features, and validation documentation
Ensure data integrity, security, and protect intellectual property
Understand the current computer system industry standards for

security, data transfer, and audit trails
Electronic signatures, digital pens, and biometric signatures

Who Will Benefit:
IT
QA
QC
Laboratory Staff
Managers
GMP, GCP, GLP Professionals

Speaker Profile:
Edwin Waldbusser is a consultant retired from industry after 20 years

in management of development of medical devices (5 patents). He

has been consulting in the US and internationally in the areas of

design control, risk analysis and software validation for the past 8

years. Mr. Waldbusser has a BS in Mechanical Engineering and an

MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a

member of the Thomson Reuters Expert Witness network.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

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WHEN AND WHERE

10 September 2018
United States of America

ORGANIZER

Netzealous LLC DBA - Compliance4All

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Added 5 years ago by Compliance4All on Health