Training Activities For Usfda (pharma) - ZIP Download

Dear All,
Does anyone have some information and experience to share regarding Training activities for USFDA compliance for Pharma industry?
Thanks !
Hiten

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

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

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

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

Hello Hiten, Amit
Can I also get some sample SOPs and training material for Pharma co. relating to HR. I am new in pharma co. joined in HR. It will be very useful for me.
Thanks
Divyang
email : [Login to view]

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

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 [Login to view]
warm regards
Nishant Joshi

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 - [Login to view]. at the same time I will also make something and send to you. Then we can arrive at something common.
Regards,
Hiten

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