Computerized System Validation - A Detailed Insight

Speaker

Instructor: Harry Huss
Product ID: 702536

Location
  • Duration: 90 Min
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.
RECORDED TRAINING
Last Recorded Date: Dec-2012

 

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

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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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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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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