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Webinar on Drafting a Software VandV Documentation Package and Protocol

3/18/2014 10:00 AM - 11:00 AM

Overview:

The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.

This webinar will address the use of the FDA, DAMP, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, to 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 realistly accomplished.

This webinar will address software that is:

As-Product;

In-Product;

In Production and Test Equipment; and

The Quality System.

A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process.

Areas Covered in the Session:

Verification or Validation

Current Regulatory Expectations and “Hot Buttons”

The Project Validation Plan

Product and Process / Equipment Software V&V

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

GAMP Considerations

The FDA's 11 Key Elements

"White Box" and "Black Box" Validations

Who Will Benefit:

Senior management, Project Leaders, Internal / External consultants

Mid-level Management and Supervisory Personnel

Regulatory Affairs

Quality Systems Personnel / QAE

R&D and Engineering Staff

New Product Development Personnel

Validation Technicians

IT Department

Medical Device, Equipment / Process SW Programmers

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. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

Contact Information:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/MQdBrI

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