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


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Who should attend?

QC Laboratory Staff Managers GMP, GCP, GLP Professionals

Details

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: support@compliance4All.com

Prices

One Dial-in One Attendee Price: $150.00

Contact

Event Manager
support@compliance4all.com

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