Software verification and validation planning
The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.
Why you should attend: Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Software is being developed for medical imaging, and even though control of computer for individuals having disabilities restricting hand or eye movement/coordination. The U.S. FDA rightly recognises that virtually all software quality problems occur in the design, testing and validation phases, since replication of software is relatively defect-free. Regulatory auditors are more comfortable with delving into software issues. Recent problems in unrelated industries show the dangers of neglecting thorough, and risk based software verification and validation activities. Effective and real world software V&V is even more important in today's resource constrained industrial environment.
Areas Covered in the Session:
Verification or Validation
Current Regulatory Expectations and Recent Audit "Hot Buttons"
The Project Validation Plan
Product and Process/Facilities/Equipment Software V&V
When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
GAMP/Other Considerations
The FDA's 11 Key V&V Documentation Elements
21 CFR Part 11, QMS, Electronic Records/E-Signatures
"White Box" and "Black Box" Validations
Who Will Benefit:
Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations
Consultants
Venue: online training webinar, Wilmington
Cost: Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00
More info:
online training webinar