Webinar on Drafting a Software V&V Documentation Package and Protocol

Event Details

Time: May 25, 2016 from 10am to 11am
Location: Online Event
Street: 161 Mission Falls Lane, Suite 216
City/Town: Fremont
Website or Map: http://bit.ly/Drafting_a_Soft…
Phone: 18004479407
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Mar 29, 2016

Export to Outlook or iCal (.ics)

0 members like this

Event Description

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

Speaker Profile:

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. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/Drafting_a_Software

LinkedIn Follow us
Twitter Follow us
Facebook Like us