Computerized System Validation - A Detailed Insight
Instructor:
Harry Huss
Product ID: 702536
- Duration: 90 Min
Why Should You Attend:
The FDA has issued a series of regulations and guidelines to define regulatory expectations for computerized system validation. In today’s medical environment, virtually all aspects of research and manufacturing are conducted using computerized systems, yet the planning, conduct, and necessary controls for validation of these systems remains problematic for many companies and industry professionals.
This 90-minute training will diminish the mystery associated with computerized system validation, provide attendees with a clear understanding of the concepts of system validation, and describe the steps to be taken by a project team leading to a well-controlled and successful computerized system validation.
Areas Covered in this Webinar:
- Introduction, Historical Perspective, and Definitions.
- Computerized System Validation Master Plan.
- Validation Plan.
- Developer Assessment.
- Requirements, Design, and Configuration Specifications.
- Validation Testing.
- Procedures/Archival/Traceability.
- Validation Summary Report
- Commissioning Memo
- System Decommissioning/Retirement
- Questions & Answers
Who Will Benefit:
- Project/Strategic Management
- Quality Assurance staff
- IT staff
- Operations staff
- Regulatory Professionals
- System Administrators
- Validation Professionals
Harry Huss, has over 30 years of experience in the pharmaceutical/medical industry. He is currently Chief Compliance Officer, Touchstone Technologies Silicon Valley; and has held positions as Executive Directive, Brandywine Compliance Consulting; Senior Director Compliance Policy & Program Support Services, Charles River Laboratories; Associate Director of Computer Validation Quality Assurance, Merck & Company; and Regulatory Compliance Manager, SmithKline Beecham. Harry has a M.S. degree in Clinical Microbiology from Thomas Jefferson University, and B.S. degrees in Biology and Medical Technology from Millersville University and Bryn Mawr respectively. He has provided numerous computer validation and Part 11 presentations at professional meetings, provided computer validation training for the FDA, authored a Master Validation Plan for the FDA National Center for Toxicological Research (NCTR), and published a variety of scientific and regulatory compliance articles. Harry is a member of the Drug Information Association Validation SIAC Core Committee and a member of the Society for Quality Assurance Computer Validation Initiatives Committee (CVIC).
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