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COURSE ID 3027

Computer System Validation: A Regulatory Overview

AVAILABLE On-demand
90 Minutes

On-Demand

Offering Price
$ 295
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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

ACCREDITATION CEU's - 0.2 IACET
View Course Outline

The ever-increasing use of computers within the life science industries draws the attention of the FDA and international regulatory agencies. In recent years we have moved from simple record-keeping systems to computer-controlled processing, manufacturing, devices, and inventory systems. As we look forward to the increasing use of artificial intelligence, we will require increasingly sophisticated computers, trained users, skilled IT professionals, and involved management.

This 90-minute accredited ON DEMAND course is designed to provide an introduction and overview of key topics, regulations, tools, guidance’s, and foundational principles that guide computer system validation.

Topics include:

FDA, GAMP, MHRA, ISO, and MDD

who should
attend?

LEVEL
Introductory
INTERESTS
Biotechnology / Biopharmaceutical Medical Devices / Diagnostics Pharmaceutical Science & Technology

This course is intended for professionals in the life science industries working in all facets of computer system validation. The course addresses the regulatory requirements and industry guidance that should drive the CSV efforts in the life science industries for the following personnel:

– System Users

– Project Managers

– IT Professionals

– Regulatory Staff

– Auditors

– System Vendors

– Validation Test Managers and Engineers

– Validation Managers and Engineers

– System Developers, Designers, and Integrators

– Quality Assurance and Control Staff

Professionals who manage staff in any of these areas would also benefit from this course by gaining a better understanding of the current regulations and most recent issues.

 

 

course instructor

Philip E. Sax
Consultant to the Life Science Industry

Philip E. Sax’s Courses
Phil Sax is an early thought leader for CSV. A Founder and President of Weinberg Spelton and Sax, a Computer System Validation Consultancy, he has been involved in hundreds of successful validation projects. He has trained more than 1000 professionals, including FDA staff, and has served as Vice President and Chief Regulatory and Quality Officer for 3 international companies. Phil has consulted and worked in 19 countries throughout North America, Europe, Asia, and the Middle East. Phil testified to the US House of Representatives about Computer System Validation issues. Since 2014 Phil as served as an Adjunct Assistant professor in the Masters of Regulatory Affairs and Quality Assurance Program of the Pharmacy School at Temple University. He has developed and directed courses in Validation, Good Clinical Practices, and Drug Development, He maintains an active compliance and regulatory affairs consultancy.

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