Identifying and resolving common issues in FDA Software Validation & Verification

[Adam Fleming]

Verification and Validation (V & V) are two important aspects of regulatory compliance for software. What all are needed for achieving this? The FDA, GAMP and others provide guidance in the methodology and documentation needed for this. This apart; 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.

The U.S. FDA has stated that software validation can only be risk-based. This applies to software: a) As-Product; b) In-Product, c) In Production and Test Equipment, and d)  The Quality System. This webinar will take a look at these.

A learning session to help understand the nitty-gritty of V & V

To offer complete understanding of the topic of V & V for medical device software, Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a webinar.

John E. Lincoln, a senior medical device and regulatory affairs consultant, will be the Speaker at this webinar. Just visit http://www.compliance4all.com/control/w_product/~product_id=500816L... to enroll for this highly educative session.

All areas of the use of FDA, GAMP, and other models

This webinar will address the use of the FDA, GAMP, and other applicable industry Software Validation, professional trainings, medical device software, organizing a webinar, software validation models. It will supplement these with the ISO 14971 model to structure, run, and document acceptable software validations.

It will cover these areas:

o  Verification or Validation –Current Regulatory Expectations

o  The Project Validation Plan

o  Product Software Validation and Process/Equipment Software Validations –how they differ

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

o  ISO 14971:2007 Issues

o  GAMP Guidance

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

o  “White box” and “Black box” Validations

o  ‘Real World’ Considerations