This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity, and explains about the regulation and how it applies to computerized systems.
At a Glance
Registration Fee: $$150
Date and Location
Tuesday, January 16, 2018 -
10:00am to 11:30am
161 Mission Falls Lane, Suite 216,
Point of Contact
A point of contact has not been selected for this event.
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:
GMP, GCP, GLP Professionals
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