Compliance4All, Online
2017-03-08
Overview: 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 R&D
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