Computer Compliance & Cloud Impact Part-Online Training

Computer Compliance & Cloud Impact The Auditable Validation

www.onlinecompliancepanel.com | 510-857-5896 | [email protected]

http://www.onlinecompliancepanel.com/

Instructor Profile


Dr. Stokes worked as a Medical Technologist in hospitals, researches, and central laboratories. Her transition to computers came from troubleshooting systems reporting laboratory results. She joined Digital Equipment Corporation (DEC) for a 16 year career focused on pharmaceutical computer solutions. Based in Basel, Switzerland 1990-1995, she developed DEC's computer validation consulting practice for customers across Europe and in Japan with a focus on reality-based compliance to global good practice (GCP, GLP, GMP) regulations.


Description

This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.



Why should attend

Industry and IT professionals both new and experienced in computer validation are facing new compliance challenges

around the implementation of SaaS and other Cloud technology services for regulated data and GXP operations.



Objectives


Understand what is expected in Part 11 and Annex 11 inspections Avoid 483s and Warning Letters Learn how to buy COTS software and qualify vendors Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds e system evolution Minimize the validation documentation to reduce costs without increasing regulatory or business risk Write test cases that trace to elements of risk management Protect intellectual property and keep electronic records safe


Who can Benefit


Regulatory Affairs QA/QC IT/IS Software Managers Project Managers Software Vendors and Suppliers


How this Webinar Works


Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat

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Computer Validation


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Computer Compliance & Cloud Impact Part-Online Training

Documents

Transcript of Computer Compliance & Cloud Impact Part-Online Training