Bioequivalence and Bioavailability Forum • QA Training: SOPs, protocol

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

posted by chidambarajoshi – Hyderabad-INDIA, 2008-11-17 12:08 (6425 d 22:36 ago) – Posting: # 2684
Views: 25,587

❝ QA personnel may not need the same level of "SOP training" that the

❝ personnel who will use them, but obviously they have to know what's

❝ inside. Same for the protocol, at least if there are specific requirements

❝ compared to the standard protocol you use.

I do admit to Ohlbe. But it will be QA's responsibility to answer to for either sponsor or regulatory query. For this at least the QA person should have knowledge of all SOPs (Clinical/Bioanalytical/Stat).
As for as protocol is concerned if QA a part of protocol reviewing team training can be skipped.
Regards
Joshi

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Edit: Follow-up post removed (you may edit your own post within 24 hours). [Helmut]

—
Best Regards
Joshi

Complete thread:

QA Training vish14184 2008-11-15 09:35
- QA Training: SOPs, protocol Ohlbe 2008-11-15 13:16
  - QA Training: SOPs, protocolchidambarajoshi 2008-11-17 11:08
    - QA Training: SOPs, protocol vish14184 2008-11-18 09:12
      - QA Training: SOPs, protocol mbshankar 2008-11-18 11:31
        
        QA Training: SOPs, protocol chidambarajoshi 2008-11-18 12:00
        
        QA Training: SOPs, protocol mbshankar 2008-11-18 12:43
        
        QA Training: SOPs, protocol chiragkhatri 2008-11-19 05:56
        
        QA Training: SOPs, protocol chidambarajoshi 2008-11-19 07:28
        
        QA Training: SOPs, protocol mbshankar 2008-11-19 10:43
        
        QA Training: SOPs, protocol chidambarajoshi 2008-11-19 11:45
        QA Training: SOPs, protocol chidambarajoshi 2008-11-19 11:47
        
        QA Training: SOPs, protocol mbshankar 2008-11-20 06:46
        
        QA Training: SOPs, protocol vish14184 2008-11-20 09:37
        QA Training: SOPs, protocol chidambarajoshi 2008-11-21 05:43
        
        QA Training: SOPs, protocol mbshankar 2008-11-22 05:09
        
        QA Training: SOPs, protocol chidambarajoshi 2008-11-24 11:22
        
        QA Training: SOPs, protocol mbshankar 2008-11-24 12:22
        
        QA Training: SOPs, protocol Ohlbe 2008-11-24 12:41
        QA Training: SOPs, protocol chidambarajoshi 2008-11-24 12:49
        LLOQ / Cmax Helmut 2008-11-24 12:54