Electronic Signatures 2017 - Equipment and QMS Software by Verification Process

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
Speaker Profile:
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.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support-AT-compliance4All.com