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From GlobalCompliancePanel
A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP
...nce of "controlled documents" as well as their update and archiving. The U. S. FDA has eliminated it's "selective enforcement" policy and is looking for proper implementation of the control of electronic records and electronic signatures, that can withstand legal review in a court of law. Companies may try to say they are using "hard copies" as their controlled documents, but this is
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Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel
...ording of GLP and GMP Raw Data.
* SOP: Retention and Archiving of Electronic Records
* Checklist: FDA Record Retention and Retrieval
Areas Covered in the Session:
* FDA Requirements for raw data and meta data
* FDA Inspection and enforcement practices
* Recommendations from industry task forces: GAMP/ ISPE guides
* Definition of raw data: original records vs.
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