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.

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


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