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Common Sense Computer Validation
This interactive seminar teaches a practical approach to use for computer validation
suitable for both non-IT professionals such as QA and system owners and IT professionals.
It describes the common compliance themes for all regulations and defines an industry
standard way to address Operational Qualification (OQ) by the software supplier,
installation qualification (IQ) by the data center, and Performance Qualification
(PQ) by the end users in their regulated work process. It also discusses ways to
ensure audit friendly test documentation and how to maintain a validated state after
the system goes live.
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Interactive Tutorials include the following topics:
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Participants will be able to:
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Global Regulations and Common Compliance Themes - From FDA
Blue Book in 1973 to the Present for GMP, GLP, GCP and 21 CFR Part 11.
How to Perform Computer Validation with OQ/IQ/PQ Variations for Supplier, IT and
End User – System Control, Human Control, Testing Control.
Formal Testing Practices for Auditable Test Results - Roles & Responsibilities for
Script Author, Reviewer, Tester and Witness, Requirements and Trace Matrix, Test
Script standard elements and formal result recording practices.
Maintaining a Validated State after Go-Live - Change Control, Configuration Management,
Disaster Recovery & Business Continuity Plans, Ongoing test Plan and Master Plan
Process.
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Describe common global regulatory themes for computer validation.
Assess the different roles and responsibilities for normal testing in validation
work.
Identify standard format and function for key validation documentation.
Assess the completeness and quality of a computer-system validation package to an
industry standard.
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Instructor, Dr. Teri Stokes is an international consultant and expert on the topic
of computer systems validation to the pharmaceutical, biotech and healthcare industries
and their system suppliers. Her special focus is the development of corporate policy
and its practical implementation through to project level activities across international
sites for systems operating under regulations for GLP, GCP, CMP and Electronic Records.
Dr. Stokes author of numerous books and articles has a Bachelors Degree in Biology
from Boston University and a professional registration as a Medical Technologist,
M.T. (ASCP). She earned her Master’s Degree in Management from Lesley University,
and her PhD in Management from Walden University.
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WHEN :
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October 18, 2010 |
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WHERE :
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Best Western Royal Plaza
Marlborough, MA |
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Course Code :
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100 |
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TIME :
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9:00 am to 5:00 pm |
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TO REGISTER PLEASE VISIT OUR WEBSITE.
NEQC Administration, Phone: (508) 987-3800 Fax: (508) 987-1464
E-mail: Registration@neqc.org
Website: www.neqc.org
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