Webinar 2013 - Risk-based Software Verification and Validation - Webinar by GlobalCompliancePanel

Overview: The FDA, GAMP and others provide guidance in the methodology and documentation to achieve this. Consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V. This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
The U.S. FDA has stated that software validation can only be risk-based. This applies to Software:
As-Product
In-Product
In Production and Test Equipment, and
The Quality System.
Areas Covered in the Session:
Verification or Validation - Current Regulatory Expectations
The Project Validation Plan
Product Software Validation and Process / Equipment Software Validations - how they differ
When and How to Use DQ, IQ, OQ and PQ
ISO 14971:2007 Issues
GAMP Guidance
The 11 Key Elements of the Software V&V Model
"White box" and "Black box" Validations
'Real World' Considerations
Who Will Benefit:
Senior Management, Project Leaders
Internal / External Auditors and/or Consultants
Regulatory Affairs
Quality Systems Personnel / QAE
New product development, Marketing and R&D
Software Product and Process / Manufacturing Engineering Staff
Document Control
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.
NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Event Link - http://bit.ly/12nh7uq