Training of SOPs [GxP / QC / QA]

posted by Pandu – India, 2019-03-27 07:51 (663 d 03:00 ago) – Posting: # 20086
Views: 1,736

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.

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