Log in
RegisterQA Training: SOPs, protocol [GxP / QC / QA]
Dear Vishal Nakrani,
This is shankar sir of ARCP. Now working as Manager QA for a CRO that is involved in BE.
The protocol training must be given and documented so that the auditor knows what to look for and as u said, all of those who audit are do not review protocol. However during the study if you depute QA personnel for overall monitoring (critical areas) of the conduct of study the protocol specific activities can been monitored for right conduct. I too was under impression that there may be need for training in all SOPs, but the coplience to SOPs can be verified by refering the SOPs present at the site of operation. When designated auditor visits the facility for internal audit he/she can go through the SOPs before conducting the audit.
--
Edit: Full quote removed. Please see this post! [Jaime]
This is shankar sir of ARCP. Now working as Manager QA for a CRO that is involved in BE.
The protocol training must be given and documented so that the auditor knows what to look for and as u said, all of those who audit are do not review protocol. However during the study if you depute QA personnel for overall monitoring (critical areas) of the conduct of study the protocol specific activities can been monitored for right conduct. I too was under impression that there may be need for training in all SOPs, but the coplience to SOPs can be verified by refering the SOPs present at the site of operation. When designated auditor visits the facility for internal audit he/she can go through the SOPs before conducting the audit.
--
Edit: Full quote removed. Please see this post! [Jaime]
Complete thread:
- QA Training vish14184 2008-11-15 09:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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, protocolmbshankar 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
- QA Training: SOPs, protocol mbshankar 2008-11-24 12:22
- QA Training: SOPs, protocol chidambarajoshi 2008-11-24 11:22
- QA Training: SOPs, protocol mbshankar 2008-11-22 05:09
- QA Training: SOPs, protocol mbshankar 2008-11-20 06:46
- QA Training: SOPs, protocol mbshankar 2008-11-19 10:43
- QA Training: SOPs, protocol chidambarajoshi 2008-11-19 07:28
- QA Training: SOPs, protocol chiragkhatri 2008-11-19 05:56
- QA Training: SOPs, protocol mbshankar 2008-11-18 12:43
- QA Training: SOPs, protocol chidambarajoshi 2008-11-18 12:00
- QA Training: SOPs, protocolmbshankar 2008-11-18 11:31
- QA Training: SOPs, protocol vish14184 2008-11-18 09:12
- QA Training: SOPs, protocol chidambarajoshi 2008-11-17 11:08
- QA Training: SOPs, protocol Ohlbe 2008-11-15 13:16
Ing. Helmut Schütz