The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based".How can this be done in the "real world".
Why should you 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. A quick review of Internet forums will show much confusion about the subject.
Areas Covered in the Session:
Verification or Validation-FDA Expectations
The Project V&V Plan
An FDA-accepted Documentation "Model"
Product and Process/Test Facilities/Equipment Software V&V
Who Will Benefit:
Senior management in Drugs,Devices,Combination Products,Biologics,Dietary Supplements
QA / RA
Software development,Programming,Documentation,Testing teams
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.
Compliance4All DBA NetZealous,