- URL: http://www.lifesciencetraininginstitute.com/doc/auditing-validated-computer-systems-in-a-gxp-environment-training-course-0001
- Date: 11/29/2016
- Listed: November 14, 2016 9:59 am
- Expires: This ad has expired
Auditing Validated Computer Systems In A GxP Environment
Date: November 29, 2016
Time: 1:00pm-2:30pm, EST US
Price: $299 – Includes Bonus Handouts!
Validation of computer systems is a legal requirement within the pharmaceutical, biotech, and medical device industries. Given the current regulatory and industry focus on electronic data integrity, adequate control over electronic data systems is coming under more scrutiny. Quality personnel are often tasked with auditing and/or reviewing computer systems validation packages, whether for internal business groups or outsourced businesses that collect or generate regulated data on behalf of the sponsor firm. Technical management, principal investigators, study directors, and similar personnel can also be tasked with reviewing the adequacy of a system’s validation status prior to approving its use on a regulated activity, but what are the critical items to look for?
The purpose of this training is to present techniques and strategies for auditing computer systems validation documentation for compliance to applicable global regulations, plus internal policies and SOPs. Current issues including cloud systems and data integrity will be discussed.
Learning objectives include:
A review of regulatory requirements for computer systems validation
Understanding the basic components of a computer systems validation package
Identify high-risk areas within a computer systems validation project
Identify where to look in documentation for evidence of specific testing of critical system functions
Learn how to audit change control and periodic review documentation to help assure the maintenance of the validated state
Strategies for reporting and mitigating issues identified
Common mistakes and pitfalls to avoid when auditing your systems
Who Should Attend
This course will be of benefit to anyone involved the validation, use, and maintenance of regulated computer systems within GxP environments. This course will be highly-relevant to those in quality assurance, validation, IT, and other job functions responsible for auditing or reviewing the validation, use, and maintenance of computer systems and associated data.
Alecia Adams, RQAP-GLP, PMP, ASQ CSQE, is a software implementation and compliance consultant and the founder of Compliant Systems Services, LLC, in Charlotte, NC. She helps biotechnology, pharmaceutical, and medical device companies find and implement computerized systems that increase efficiency, sustain compliance, and ease business pain. Ms. Adams has 18 years of combined experience in technical operations, quality assurance, and information technology. She earned her B.S. in Biochemistry from the University of Southern Mississippi and is continuing her education at the Johns Hopkins University, where she is earning her M.S. in Bioinformatics and focusing on the potential of big data and cloud computing in the area of personalized medicine. She is an active member of the American Society for Quality (ASQ) as well as the Society of Quality Assurance (SQA) and its Computer Systems Validation Initiative Committee (CVIC).
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