Video

Thank you very much Sir

If UCL and LCL are out side from the specification during normal analysis, then how the control limit will be determined for implementation ?

Very nicely explained all important points. Thanks

Yes I need

In PQR how we justify that which tool is useful for less number of batches and large number of batches?

Hi sir

You can download the training presentation from the link below - we.tl/t-SG2nFrVncw The link will expire within couple of days. So, download ASAP.

Sir can u pls share the PPT to me

PLC and scada comes under which category of GAMP

Nice sir

Please provide material

Hello Sir, I didn't find KPI in ICH Q7

what is the difference between approaches and technique and when we have to use approach or technique?

Thanks great content

A very informative & helpful content. Thank you sir. For your effort to have learnt me

Any Detail Webinar related to ISO 17025

Sir any Webinar related to QC Compliance

Sir plz share the link for downloading the presentation

Dear Sir, please guide us how to sellect sampling location based on risk assessment.

Very nice presentation. Thank you

Hi sir thanks for information, I'm A chemist in manufacturing department in API pharmaceutical industry......is there any courses that are use full to me for better knowledge in manufacturing

Hi sir thanks for information, I'm A chemist in manufacturing department in API pharmaceutical industry......is there any courses that are use full to me for better knowledge in manufacturing

Hi sir thanks for information, I'm A chemist in manufacturing department in API pharmaceutical industry......is there any courses that are use full to me for better knowledge in manufacturing

Is it okay to use a commercial scale batch for PQ ?

Very nice and precise explanation sir, thank you very much

Management can review through MRM meeting

Hi sir, You have mentioned that we need to perform CSV for any application, then a separate document required for CSA. Separate document means it's like a checklist kind of document whether all the CSA requirements are fulfilled or not we need to check?

If one product have many ingredients, how to calculate limit of all ingredients. Need to check each ingredient carry over to another product

Hellow sir the session was really nice and informative, could you please conduct a session on how to prepare FRA document and how to calculate risk of each and every functionality.

Thank u very much Sir ji for valuable information. I have question related to data point. As u suggested 20 data point. Please help for details information related 20 data points with example for better clarity.

Please explains change control risk assessment, impact assessment and action items for change in excipient, API vendor Change in equipment Change in area Change in location / site Introducing new product Change in batch size Change in software

Thank you sir for your valuable presentation.very useful for the interview preparation.

Why we need calculated the cp and cpk value in pharmaceutical industries

Sir can I get your contact details, we also want to plan for external training

What is the category of plc as per gamp5

www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/page-9 Retrospective process validation is validation of a process for a product already in distribution based upon accumulated production, testing and control data. Can u check the same and update us related to retrospective Validation.

Good Informative sir

Sir, Please share presentation..

Sir in many companies manpower for check by is very less or 1 no and tasks are many at same time so how one person can check everything. Because sometimes I have one 2hours task in another department so how can I do check by in my own department

Hi what if root cause is not identified

Hello Hitendrakumar, how do we confirm the supply chain traceabiility of the API? Also when listing all the starting materials used, what is the purpose of this?

Nice easily understand all topics Sir my question is If same Equipment which are already qualified they are transferred from Plant A to plant B then qualification is again required ??