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Which data and systems are subject to Part 11


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Who should attend?

Laboratory Staff Managers GMP, GCP, GLP Professionals

Details

Overview:  
This webinar details the regulation and how it applies to computerized
systems. 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.

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

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.

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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