FDA Computer Validation 101: Basic Fundamentals
Who should attend?
Professionals who work in the healthcare, pharmaceutical, life science, biotechnology, medical-manufacturing, medical device, and other highly regulated industries in the following areas:
- FDA/GxP/GAMP Compliance
- Validation
- IT
- Quality Assurance
- Training
- Manufacturing
Join us for a Webinar on February 9th
Space is limited.
Reserve your Webinar seat now at:
https://www2.gotomeeting.com/register/891815706
This webinar will provide an overview of what is meant by computer validation. Participants in the webinar will learn the fundamentals of what computer systems require validation, when validation should be performed, who is responsible, how do you validate a computer system and where to go for references and guidance.
Topics covered:
- Overview of regulatory framework (FDA) and requirements
- Introduction to computer system validation (CSV)
- Commercial off the shelf (COTS) software
- Embedded software
- Information Management Systems
- Software development life cycle / project life cycle
- Fundamentals and typical documentation of :
- User requirements,
- Design requirements,
- Installation Qualification (IQ),
- Operational Qualification (OQ),
- Performance Qualification (PQ)
- Brief description of the role of risk management in the validation process.
Title:FDA Computer Validation 101: Basic Fundamentals
Date: Tuesday, February 9, 2010
Time:2:00 PM - 3:00 PM EST; 1:00 PM - 2:00 PM CST; Noon - 1:00 PM MST; 11:00 AM - Noon PST
After registering you will receive a confirmation email containing information about joining the Webinar.
System Requirements
PC-based attendees
Required: Windows® 2000, XP Home, XP Pro, 2003 Server, Vista
Macintosh®-based attendees
Required: Mac OS® X 10.4 (Tiger®) or newer
Check out our previous seminars in the Compliance Validation Series
About SyberWorks
SyberWorks, Inc. (www.syberworks.com) is a leader in the custom and Learning Management System industries for Fortune 1000 corporations, higher education, and other industries. Located in Waltham, Massachusetts, the company serves the multi-billion-dollar e-Learning market. Since 1995, SyberWorks has developed and delivered unique and economical solutions to create, manage, measure, and improve e-Learning programs at companies and organizations in the United States, Canada, Europe, and other countries.
About Focus Compliance & Validation Services, Inc.
Headquartered in Knoxville, TN, Focus Compliance & Validation Services, Inc. (Focus CVS) (www.focuscvs.com) is dedicated to providing regulatory compliance, validation, and process engineering services to the pharmaceutical, biotechnology, and medical device industry. Focus CVS is an innovative solutions provider to the U.S. Food & Drug Administration (FDA) regulated industry.
Focus CVS delivers services and tools helping clients understand how to integrate good software-based engineering practices into their product-development methodologies for the purpose of FDA regulatory compliance.
Based on FDA and other regulatory agencies’ governance and guidance criteria and first-hand experience, Focus Compliance & Validation Services defines applicable risk-based validation principles and best practices. These principles and best practices apply to processes that are used in, and the facilities and controls that are used for, Design, Manufacturing, Packaging, Labeling, Storage, Installation, Support, Servicing, and Retirement of regulated software-based products. Through integration of these principles, clients avoid and mitigate regulatory-agency scrutiny and comply with the Federal Food, Drug, and Cosmetic Act. For more information, visit www.focuscvs.com.
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