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

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

Jan 11, 2016 - Jan 11, 2016
Event Type: Webinar
Time: Jan 11, 2016 8:00 - Jan 11, 2016 9:30
Make sure to select correct standard or daylight time zone for your location on this event date
Location: Online Event
Registration Deadline: Jan 11, 2016
Abstract Submission Deadline: Jan 11, 2016

Description of event:

 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
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.



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