Boston Professional Events List


Live Webinar : Software / Firmware Verification and Validation to Meet Regulatory Requirements


Date
Oct 06, 2017 - 07:00 PM
Organizer
wcsseminars
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Hollywood,
FLORIDA,
United States,
ZIP: 33021
Phone: 347 282-5400

Ticket Price: $179 One Dial-in One Attendee, $395 Group, $249 Recorded, $295 CD/DVD
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.  This webinar will address the use of the FDA, GAMP®, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.  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".
 
Areas Covered

 

  • Verification or Validation -- FDA Expectations
  • An FDA- [and ISO-] accepted Documentation "Model"
  • The FDA’s 11 Key V&V Documentation Elements
  • The Project V&V Plan
  • Product and Process / Test / Facilities / Equipment Software V&V
  • When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
  • “White Box” and “Black Box” Validations
  • IEC 62304, GAMP® / Other Considerations

 

Who will Benefit

 

• Corporate Management

• QA

• RA

• R&D

• Engineering

• Production

• Marketing



Speaker Details


John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. 

Event Categories
Keywords: Education




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