Pandu
★    

India,
2019-03-25 11:16
(621 d 12:39 ago)

Posting: # 20081
Views: 2,039
 

 Training of SOPs [GxP / QC / QA]

Hi,
I need clarification on Training of SOPs. My department (PK-stats) persons prepared SOPS and signed off the same. When I am raising the request for training, other department (clinical and analytical) persons are also interested to attendant the training. But in there JD's our sops were not mentioned (our sops are not related to there work).

Is it Ok for providing training for all the persons, it approved by regulators. If yes how to document for this.

If SOP version changes or revised again we have to give training for all these persons?


Thanks and regards,

Pandu
WhiteCoatWriter
☆    

India,
2019-03-25 13:13
(621 d 10:42 ago)

@ Pandu
Posting: # 20082
Views: 1,761
 

 Training of SOPs

Hi Mr Pandu,

In the regulatory environment, it is important for the person doing an activity to be adequately trained and aptly qualified. With others showing interest, I doubt your organization is planning to make everyone do PK and STAT ?

Check with your QA department on how they handle training and documents and if the concerned "other department" individuals need PK and STAT training. This should also answer who needs training and re-training when a revision happens.

I would however recommend to have a dedicated team members for PK and STAT who are well trained in handling PK data and software(s) such as SAS. The same needs to reflect in the organogram of your organization which regulatory personnel review initially at the time of audit.

Note: It could raise questions when letting bio analytical team members have access to PK and SAS systems in which randomization is expected to be generated/stored.

P.S: when you mentioned other people were interested, I'd want to say - Self interest and capability is a different point all together, however it is up to the management of an organization to decide who needs to be trained and who shall be responsible for handling data for regulatory submission purposes.

Thanks and Regards
Dr Anonymous
(WhiteCoatWriter)
Pandu
★    

India,
2019-03-27 07:51
(619 d 16:04 ago)

@ WhiteCoatWriter
Posting: # 20086
Views: 1,706
 

 Training of SOPs

Hi Dr.

Thanks for your prompt replay. I have some concerns.

» In the regulatory environment, it is important for the person doing an activity to be adequately trained and aptly qualified. With others showing interest, I doubt your organization is planning to make everyone do PK and STAT ?

No. Only my department persons only will run PK & Stats.

» Check with your QA department on how they handle training and documents and if the concerned "other department" individuals need PK and STAT training. This should also answer who needs training and re-training when a revision happens.

As per our QA Team information, Initial we can give training the SOPs for all persons (clinical and bioanalytical). For next revisions, only respective persons who involved in the activities are only get training. Is OK for regulatory point of view.

» I would however recommend to have a dedicated team members for PK and STAT who are well trained in handling PK data and software(s) such as SAS. The same needs to reflect in the organogram of your organization which regulatory personnel review initially at the time of audit.
»
» Note: It could raise questions when letting bio analytical team members have access to PK and SAS systems in which randomization is expected to be generated/stored.
»
» P.S: when you mentioned other people were interested, I'd want to say - Self interest and capability is a different point all together, however it is up to the management of an organization to decide who needs to be trained and who shall be responsible for handling data for regulatory submission purposes.
ElMaestro
★★★

Belgium?,
2019-03-27 08:14
(619 d 15:41 ago)

@ Pandu
Posting: # 20087
Views: 1,718
 

 Training of SOPs

Hi Pandu,


» I need clarification on Training of SOPs. My department (PK-stats) persons prepared SOPS and signed off the same. When I am raising the request for training, other department (clinical and analytical) persons are also interested to attendant the training. But in there JD's our sops were not mentioned (our sops are not related to there work).

By all means, do the training, also for those who are interested but not directly involved.
There more the "unrelated" people understand about processes in other departments, the better they will understand how their own function impacts the downstream activity, and it will also help them propose relevant changes to the system.
I would not in any way shy away from training them. In fact, I think you are privileged that colleagues from other functions express this interest. Cease the moment.

» Is it Ok for providing training for all the persons, it approved by regulators. If yes how to document for this.

A BE study is principally a study on rate and extent of absorption. Everything everyone does in such an organization is centered on ethical production of credible data for exactly that. Why on earth would it be an issue to train them?

» If SOP version changes or revised again we have to give training for all these persons?

That need should be determined by your own QMS. I am leaning towards only re-training those who work directly under the procedure, when it changes. The others on ad-hoc basis.

I like this post.

Pass or fail!
ElMaestro
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