This webinar on Retirement of Computer Systems will give a good understanding of FDA and equivalent international requirements and will provide recommendations and tools for effective 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 give a good understanding of FDA and equivalent international requirements and will provide recommendations and tools for effective implementation.
Areas Covered in the seminar:
- FDA and international regulations and guidelines.
- Impact of FDA's new approach for Part 11 .
- Planning for system retirement.
- Strategies for data migration and retrieval.
- Risk based archiving of e-records.
- Criteria for reprocessing of data.
- Responsibilities for system retirement.
- Conducting system retirement.
- Documentation of the retirement process.
- Costs of system retirement
Hand-outs:
For easy implementation, attendees will receive
- SOP: Retirement of Computer Systems
- Checklist: Computer System Retirement
- Master Plan template and examples: - Computer System Retirement
Who Will Benefit:
- IT Managers and staff
- Operation managers, supervisors and staff
- GLP/GMP auditors
- QA/QC managers and personnel
- Regulatory affairs
- Training departments
- Consultants
- Pharmaceutical Research
- Pharmaceutical development and manufacturing
- Medical device industry
- Contract laboratories
- CROs
Instructor Profile:
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance for Agilent Technologies. He is the editor of www.labcompliance.com , the global on-line resource for validation and compliance issues for laboratories. He is also the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber's website: www.ludwig-huber.com
