Which data and systems are subject to Part 11

Start Date : January 16, 2018
End Date : January 16, 2018
Time : 10:00 am to11:30 am

Phone : (800) 447-9407
Email : support@compliance4All.com



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:




Laboratory Staff


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

Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216,

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . 


Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

Tel: 800-447-9407
Email: support@compliance4All.com
Website: http://www.compliance4all.com/

Event Categories: Health & Nutrition.

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