Computerised System (PLC) Validation Session- I

#csv #automation #pharmaceutical #pharma #pharmaguideradhakrishna #fda #validation
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This training session will take you through an understanding of PLC and its validation.
The training will include below points;
Brief introduction of the concept, PLC, and validation strategy
Know your Trainer
Types of GXP computerized systems
Requirements for Validation
Understanding Traceability Matrix
Elements of Functional Risk Assessment(FRA)
Infrastructure Risk Assessment
Process Control System validation requirements
Identifying GXP and non-GXP systems, Criticality based on system complexity
Validation of PLC logic
Q&A Vote of Thanks
If you have any question/s, please feel free to raise your questions in the comment section. I will reply you.
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/ @hitendrakumarshah3718
Link for Brief on computerized system validation - ua-cam.com/users/liveBEqPpVDOCAU?...
Link for Equipment & instrument qualification -ua-cam.com/users/livejinEiaaJPEk?...

[@sireeshnunna]

Yes

[@hitendrakumarshah3718]

Thanks

[@anonymous-bg5mi]

Thank you very much for PLC session sir this session really help me a lot in understanding PLC validation👃

[@hitendrakumarshah3718]

Glad to hear that. Be in touch for further learnings...

[@anonymous-bg5mi]

Ok sure sir🙂

[@emmanuelnkiligi889]

​@@anonymous-bg5mi thanks very much for the PLC training

[@emmanuelnkiligi889]

I had a question on cleaning method validation

[@mayurpawar2187]

Very knowledgeable presentation sir
..

[@hitendrakumarshah3718]

Thanks.

[@ShraddhaChandwadkar]

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.

[@hitendrakumarshah3718]

OK

[@user-nr2xk8cm6z]

yes

[@hitendrakumarshah3718]

Thanks. Please share the link of learning video with your colleagues so that, they can also get benefit from this learning.

[@darshgamingjunction73offcial]

What is the category of plc as per gamp5

[@hitendrakumarshah3718]

It is complex system. You need to evaluate softare and hardware both of the PLC then can be evaluated.

[@aasthadancer7215]

Yes

[@hitendrakumarshah3718]

Thanks