Bioequivalence and Bioavailability Forum • QA Training: SOPs, protocol

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

posted by mbshankar – 2008-11-20 07:46 (6414 d 01:21 ago) – Posting: # 2743
Views: 25,377

Dear Joshi,
I too was looking forward for such forum where we can discuss all activities. I thank you for your promting on this issue. I wish to discuss two issues.
1. Trainig of staff at a facility (clinical and bioanalytical)
2. The activity of QA in the bioanalytical area (this is tricky bec we are cannot claim to be GLP copliant. Daily i wish to put one aspect on each Issue so let me start today...(later we will take up auditing various activites follwoed by Validation issues in IT)
1. Training: Given the situation that the field is not too old its difficult to get trained staff and also the management cant approve the training expenditures. And the sponsors insist on trained staff and the confidentiality issues make it dificult for you to go and have a look at other established CROs for systems. SO i think we have to evolve day by day into a good system.
2. QA- in Bio analytical (BA) work.: My question is What are the crucial areas of BA activites that can be audited online to ensure quality of data produced?
Regards and thanks again for initiating the discussion.

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Edit: Full quote removed (like in all your previous posts)! 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, 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, protocolmbshankar 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