Bioequivalence and Bioavailability Forum • QA Training: SOPs, protocol

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

posted by chidambarajoshi – Hyderabad-INDIA, 2008-11-24 12:22 (6416 d 18:19 ago) – Posting: # 2781
Views: 25,177

Dear Shankar

❝ The GLP required QA to be very independent and QA should always be.

IMHO irrestive of GLP / Non GLP QA is independent.

❝ Regarding training of all staff: QA i think shall ensure that the staff are trained in their areas where as the department head is responsible to abide by this dictum. And verify the training records or personnel while doing the documentation review for both clinical and bioanalytical work.

Yes!
One more thing QA needs to look in to the Incurred sample analysis.
Regards,
joshi

—
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, 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, 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, protocolchidambarajoshi 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