QA Training: SOPs, protocol [GxP / QC / QA]

posted by vish14184 – India, 2008-11-20 10:37 (6418 d 04:06 ago) – Posting: # 2746
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Dear Sankar sir,

Nice to meet u again.I am ur student from ARCP (from Nadiyad). I am also working in QA department (BA/BE study).

QA role in Bio Analytical
  1. Review of Method SOP/Protocol
  2. MV/Study sample Analysis In process Audit:- In which check bulk spiking,processing etc. perform as per Method SOP/Protocol and documentation.
  3. Retrospective audit of BA data
  4. Review of Final Report of MV/Study as per regulatory requirement
  5. Performing System audit on regular basis
  6. Involve in instrument/Equipment validation activity

Regards
Vishal Nakrani

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