Bookmark Add to Calendar

The Most Common Problems in FDA Software Validation & Verification

Duration : 90 Minutes

John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide.  He specializes in quality assuranc Read more

This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.

The U.S. FDA has stated that software validation can only be risk-based. This applies to Software:

• As-Product

• In-Product

• In Production and Test Equipment

• The Quality System

Course Objetives:

A manufacturer is responsible to identify those risks, and take reasonable steps to address them in the software validation process. The FDA, GAMP and others provide guidance in the methodology and documentation to achieve this. Consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V.

Course Outline:

• Verification or Validation - Current Regulatory Expectations

• The Project Validation Plan

• Product Software Validation and Process / Equipment Software Validations - how they differ

• When and How to Use DQ, IQ, OQ and PQ

• ISO 14971:2007 Issues

• GAMP Guidance

• The 11 Key Elements of the Software V&V Model

• "White box" and "Black box" Validations

• 'Real World' Considerations

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

• Senior Management, Project Leaders

• Internal / External Auditors and/or Consultants

• Regulatory Affairs

• Quality Systems Personnel / QAE

• New product development, Marketing and R&D

• Software Product and Process / Manufacturing Engineering Staff

• Document Control

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

Contact Us

Similar Trainings

Developing a Validation Master Plan
LIVE : Scheduled on 20-September-2021 :01:00 PM EDT
FDA Compliance and Clinical Trial Computer System Validation
LIVE : Scheduled on 22-September-2021 :01:00 PM EDT
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
LIVE : Scheduled on 30-September-2021 :11:00 AM EDT
FDA Regulation of Artificial Intelligence & Machine Learning
LIVE : Scheduled on 01-October-2021 :01:00 PM EDT
6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
LIVE : Scheduled on 06-October-2021 :11:00 AM EDT
paypal payment Comodo

Copyright ©2021 GRCLEARNINC.COM. All rights reserved. | DBA