Dear All, Does anyone have some information and experience to share regarding Training activities for USFDA compliance for Pharma industry? Thanks ! Hiten
From India, New Delhi
29From India, New Delhi
Dear Hiten,
You should start with TNI ( TRAINING Need Identification Metrix For all dept.)
ICH Q7A Guidelines - Training must be given by QA head
Stability Study- Training must be given by QA head
Personnal Hygene-Training must be given by HR
From India, Mumbai
You should start with TNI ( TRAINING Need Identification Metrix For all dept.)
ICH Q7A Guidelines - Training must be given by QA head
Stability Study- Training must be given by QA head
Personnal Hygene-Training must be given by HR
From India, Mumbai
Dear Hiten,
Training is a very vital role as per USFDA norms. But in Pharma it lies with QA Dept. Only HR Part covers following trainings -
1) Personal Hyiegene.
2) Pest Control
3) Security
4) Housekeeing
Your SOP's should be updated in all terms.
Other technical trainings records will be kept by QA dept.
Thanks,
Amit Shah
From India, Mumbai
Training is a very vital role as per USFDA norms. But in Pharma it lies with QA Dept. Only HR Part covers following trainings -
1) Personal Hyiegene.
2) Pest Control
3) Security
4) Housekeeing
Your SOP's should be updated in all terms.
Other technical trainings records will be kept by QA dept.
Thanks,
Amit Shah
From India, Mumbai
Thanks Abhay, Amit ! Any reference material you can suggest apart from ICH Guidelines? Also any specifice areas for softskills they stress upon? Can you share your views / experiences on TNI? - Hiten
From India, New Delhi
From India, New Delhi
Dear Hiten,
The best course material for the mentioned above topics are the SOP's itself. If you have not prepared the SOP's pl. prepare the same and use the same as a trg. course material for the other employees. Other material if you can craet will be great. Otherwise for audit purpose the SOP's are more than enough.
Thanks,
Amit
From India, Mumbai
The best course material for the mentioned above topics are the SOP's itself. If you have not prepared the SOP's pl. prepare the same and use the same as a trg. course material for the other employees. Other material if you can craet will be great. Otherwise for audit purpose the SOP's are more than enough.
Thanks,
Amit
From India, Mumbai
Hi ! I am developing some SOPs for training. I am attaching the draft for your reference. I will be glad to have your feedback and suggestions for improvement. - Hiten
From India, New Delhi
From India, New Delhi
dear all,
thanx for the info. but i like to request all specially who are from pharma industry on KPI and KRA for chemists, supervisors and depts. i had been searching help on this from long time. hope i get it this time...
thanx
if u have any formats/samples/ppts than mail to
warm regards
Nishant Joshi
From India, Bicholim
thanx for the info. but i like to request all specially who are from pharma industry on KPI and KRA for chemists, supervisors and depts. i had been searching help on this from long time. hope i get it this time...
thanx
if u have any formats/samples/ppts than mail to
warm regards
Nishant Joshi
From India, Bicholim
Hi Nishant,
You can search for KPAs and KRAs in search query or download query on this site. I dont think there will be readymade KPA, KRA for pharma staff but atleast you will get the fundamentals of KPA, KRA on which you will have to prepare them for your requirements yourself.
I suggest you make some drafts and send to me -
. at the same time I will also make something and send to you. Then we can arrive at something common.
Regards,
Hiten
From India, New Delhi
You can search for KPAs and KRAs in search query or download query on this site. I dont think there will be readymade KPA, KRA for pharma staff but atleast you will get the fundamentals of KPA, KRA on which you will have to prepare them for your requirements yourself.
I suggest you make some drafts and send to me -
Regards,
Hiten
From India, New Delhi
Dear Hiten,
I am sorry for delay in reply.
I could not be able to open your training .zip file, so i am not in a position to give you the answers or suggestions.
Regarding other help to prepare the SOP's i can suggest you the guideline.
start with following points.
1) Scope
2) Eligibility
3) Defination
4) Objective
5) Forms and sheets.
Eg. Pest control
1) Scope : Define the scope for PEst Control
2) Elgibility : where and for who?
3) Defination :
4) Objective : Why Pest control?
5) Forms : 1) Daily checklist 2) Fortnightly checklist 3) Monthly Checklist.
Hope now you will start preparing the same.
Thanks,
Amit
From India, Mumbai
I am sorry for delay in reply.
I could not be able to open your training .zip file, so i am not in a position to give you the answers or suggestions.
Regarding other help to prepare the SOP's i can suggest you the guideline.
start with following points.
1) Scope
2) Eligibility
3) Defination
4) Objective
5) Forms and sheets.
Eg. Pest control
1) Scope : Define the scope for PEst Control
2) Elgibility : where and for who?
3) Defination :
4) Objective : Why Pest control?
5) Forms : 1) Daily checklist 2) Fortnightly checklist 3) Monthly Checklist.
Hope now you will start preparing the same.
Thanks,
Amit
From India, Mumbai
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