« Home

Which data and systems are subject to Part 11

Tuesday, January 16, 2018, 6:00 PM - 7:30 PM


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: support@compliance4All.com

Cost: One Dial-in One Attendee Price: US$150.00
Phone: (800) 447-9407
Tickets: http://www.compliance4all.com/control/w_product/~product_id=501619LIVE?channel=kare11_Jan_2017_SEO
Event url: www.compliance4all.com/control/w_product/~product_id=501619LIVE?channel=kare11_Jan_2017_SEO

Improve this event listing

Venue

161 Mission Falls Lane, Suite 216
Fremont, CA 94539

View Map | Get Directions

More Event Ideas


Powered by Datasphere

Free Coupons in Minneapolis / St. Paul Add Your Coupon to LocalSaver

Close

What can we do for you?

Thank you for your input. Please fill out the form below and provide as much information as possible about updates to this event or venue.

Send