Events Tagged "regulatory requirements"

Implementation of the USP GMP Potency Bioassay Sui

This webinar on Potency Bioassays will show how to implement the parameters described in the new USP Bioassay suite to deliver compliant assays for Phase I/II, Phase III and commercial products.

21 CFR Part 11 and Annex 11

This webinar details both regulations and provides details for implementing computerized systems.

Audit/Inspection Preparedness for ClinicalResearch

This webinar on clinical site audit/ inspection will outline the responsibilities of the Investigator and the clinical research coordinator during and after site audits/inspections

Auditing Computer Systems for FDA

This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation.

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