Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

Why Should You Attend:

In the recent past there has been an explosion of regulatory enforcement specifically involving Computer Systems Validation (CSV), thus this webinar will demonstrate how to proper design/create, test and execute User Requirement Specifications (URS).

Who Will Benefit:

This course is designed for people tasked with developing, designing and creating User Requirements Specifications (URS) in Computer Systems Validation (CSV) in the pharmaceutical, biotech and medical device industries. This includes individuals that have quality management systems, validation, qualification and overall compliance/regulatory responsibilities within their organization.

The following disciplines will directly benefit from this webinar:

Quality Assurance

Quality Control

Regulatory Compliance

Validation/Qualification

Information Technology (IT)

Instructor Profile:

Gaurav Walia, M.S., is a pharmaceutical consultant – consent decree/computer systems validation. He has most recently worked on three major consent decree projects with McNeil/Johnson & Johnson (CSV), Novartis (third party manufacturing assessment), and b. Braun (CSV, overall QA and compliance, audits). Overall, Mr. Walia has over 19+ years of pharmaceutical experience with careers at Monsanto/Searle, Pfizer/Oread, Forest Laboratories, etc., while also serving as a pharmaceutical consultant in various disciplines from quality systems, consent decree, computer systems validation, etc.

Note:

Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2016.

For Registration:

http://www.complianceonline.com/creating-proper-user-requirement-specifications-for-computer-systems-validation-and-ensuring-overall-regulatory-compliance-webinar-training-704370-prdw?channel=sciencedz