ComplianceOnline

Computerized System Validation - A Detailed Insight

Instructor: Harry Huss
Product ID: 702536
  • Duration: 90 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This 90-minute webinar will provide a clear understanding of the concepts of computerized system validation, and describe the steps to be taken by a project team for a well-controlled and successful computerized system validation.

Course "Computerized System Validation - A Detailed Insight" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

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

Instructor Profile:

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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