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Live Webinar : Software / Firmware Verification and Validation to Meet Regulatory Requirements
Date
Oct 26, 2021 - 01:00 PM
Link to Website
Organizer
wcsseminars
Venue
Onlinewebinar
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
Description of the topic
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,
Areas Covered In the Seminar
Corporate Management
QA
RA
R&D
Engineering
Production
Marketing
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,
Areas Covered In the Seminar
- 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
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 35 years experience in U.S. FDA-regulated industries, 21 of which are as an independent consultant. John 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