ComplianceOnline

FDA Compliant Retirement of Computer Systems

Instructor: Dr. Ludwig Huber
Product ID: 700457
Training Level: Intermediate
  • Duration: 60 Min

recorded version

$249.00
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

$500.00
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 FDA compliant training for computer system will present strategies for complaint and efficient system retirement. Attendees will receive reference documents for easy implementation.

Why Should you Attend:

Retirement of computer systems used in FDA and equivalent international environments is part of the validation lifecycle and should follow well defined and documented processes. While earlier phases are well understood the industry is unsure on what to do when the systems are taken out of service. Most critical are strategies and procedures to retrieve data after system retirement. This seminar will present strategies for complaint and efficient system retirement. Attendees will receive reference documents for easy implementation.

Areas Covered in the seminar:

  • FDA and international regulations and guidelines
  • Impact of FDA's narrow approach for Part 11
  • Planning for system retirement
  • Strategies for data migration and retrieval
  • Risk based archiving of e-records
  • Criteria for reprocessing
  • Responsibilities for system retirement
  • Performing system retirement
  • Documentation of the retirement process
  • Costs of system retirement

Who Will Benefit:

  • Everybody involved in software and computer system validation
  • IT managers and administrators
  • QA managers and personnel
  • Validation specialists
  • Suppliers of software and computer systems
  • Documentation department
  • Operational departments (manufacturing, QC labs)
  • Regulatory affairs
  • Training department
  • Consultants

Additional benefits:

Attendees will receive the presenter’s SOP for Retirement of Computer Systems, a retirement plan and a checklist for system retirement

Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.

Instructor Profile:

Ludwig Huber, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press. For more information, visit Dr. Huber’s website: www.ludwig-huber.com

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