Bioequivalence and Bioavailability Forum • QA Training: SOPs, protocol

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

posted by mbshankar – 2008-11-19 11:43 (6424 d 23:16 ago) – Posting: # 2731
Views: 25,445

Dear Chirag,
Yes the discussion is interesting and important too... since its not technical or instrument related. I wish to have discussion on individual activity of QA in a BE work.
Training QA staff on all SOPs appears logical and its practical if the firm has a large team and auditing activity is well defined for individual personnel in advance delegated. But i wish to say one thing regarding change control that MR. Chidambarajoshi mentioned, not all staff review SOPs. I think if the senior staff in QA can train the new auditors in activities and ensure that they know what to look for. That should take care of it. I repeat....auditor is not same as user but then auditor should know the activity and audit it with lot of receptivity.
Regards

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Edit: Full quote removed. Please see this post! [Helmut]

Complete thread:

QA Training vish14184 2008-11-15 09:35
- QA Training: SOPs, protocol Ohlbe 2008-11-15 13:16
  - QA Training: SOPs, protocol chidambarajoshi 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, protocolmbshankar 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