Boston Professional Events List


Which data and systems are subject to Part 11


Date
Jan 16, 2018 - 10:00 AM
Organizer
Netzealous LLC DBA - Compliance4All
Venue
online
Location
161 Mission Falls Lane, Suite 216,,

Fremont,
California,
United States,
ZIP: 94539
Phone: 8004479407

Ticket Price: One Dial-in One Attendee Price: $150.00
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.

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

Event Categories
Keywords: Educationa




Comments








Events Calendar

SunMonTueWedThuFriSat
31 1 2 3 4 5 6
7 8 9 10 11 12 13
14 15 16 17 18 19 20
21 22 23 24 25 26 27
28 29 30 31 1 2 3

Event Location

Newsletters

Subscribe
VIP Life Time Subscription to our Newsletters!
$399.99
$299.99