Computer Compliance & Cloud Impact The Auditable Validation
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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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit
Regulatory Affairs QA/QC IT/IS Software Managers Project Managers Software Vendors and Suppliers
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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 Track this link
Computer Validation www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Connect with Us Online Compliance Panel
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com