Seeking Insights on Effective Training for USFDA Compliance in Pharma Industry

Dear All,

Does anyone have some information and experience to share regarding training activities for USFDA compliance in the pharmaceutical industry?

Thanks!
Hiten

Dear Hiten,

You should start with TNI (Training Need Identification Metrics) for all departments.

ICH Q7A Guidelines - Training must be given by the QA head.

Stability Study - Training must be given by the QA head.

Personal Hygiene - Training must be given by HR.

Dear Hiten,

Training plays a vital role as per USFDA norms. However, in Pharma, it is managed by the QA Dept. Only the HR department covers the following trainings:
1) Personal Hygiene
2) Pest Control
3) Security
4) Housekeeping

Ensure that your SOP's are updated comprehensively. Records of other technical training will be maintained by the QA department.

Thanks,
Amit Shah

Thanks Abhay and Amit!

Any reference material you can suggest apart from ICH Guidelines? Also, are there any specific areas for soft skills that they stress upon? Can you share your views or experiences on TNI?

- Hiten

Dear Hiten,

The best course material for the topics mentioned above is the SOPs themselves. If you have not prepared the SOPs, please prepare them and use them as training course material for the other employees. Any other materials you can create would be great. Otherwise, for audit purposes, the SOPs are more than enough.

Thanks,
Amit

Hello Hiten, Amit,

Can I also get some sample SOPs and training material for a Pharma company relating to HR? I am new in the pharma industry and have recently joined the HR department. It will be very useful for me.

Thanks,
Divyang
email: dgshah2k@gmail.com

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,

Thank you for the information. I would like to request everyone, especially those from the pharmaceutical industry, to provide insights on Key Performance Indicators (KPIs) and Key Result Areas (KRAs) for chemists, supervisors, and departments. I have been searching for assistance on this for a long time. I hope to receive some guidance this time.

If you have any formats, samples, or presentations, please email them to jnishant77@gmail.com.

Warm regards,
Nishant Joshi

Hi Nishant,

You can search for KPAs and KRAs in the search query or download query on this site. I don't think there will be a readymade KPA or KRA for pharma staff, but at least you will get the fundamentals of KPA and KRA on which you will have to prepare them for your requirements yourself. I suggest you make some drafts and send them to me at [Login to view]. At the same time, I will also create something and send it to you. Then we can arrive at a common understanding.

Regards,
Hiten

Dear Hiten,

I apologize for the delay in my reply. Unfortunately, I was unable to open your training .zip file, so I am not in a position to provide you with answers or suggestions. However, regarding other assistance in preparing the SOPs, I can offer you some guidelines.

You can begin by focusing on the following points:
1) Scope
2) Eligibility
3) Definition
4) Objective
5) Forms and sheets

For example, let's consider Pest Control:
1) Scope: Define the scope for Pest Control
2) Eligibility: Who is eligible and where?
3) Definition:
4) Objective: Why Pest Control?
5) Forms:
- Daily checklist
- Fortnightly checklist
- Monthly Checklist

I hope this helps you get started on preparing the SOPs.

Thank you,
Amit