Vendor Evaluation for cGXP Computerised Systems
Вставка
- Опубліковано 19 січ 2024
- #pharmaceutical #csv #csa #validation #quality #qrm #riskmanagement #fda #compliance #gmp #ich
This session will make you understand the "Vendor Evaluation for cGXP Computerised Systems" requirements in line with the various guideline expectations for example - EUGMP annex 11, 21 CFR Part 11, GAMP5, PIC/S guide etc.
The agenda for this session is as below;
Importance of topic
Know your Trainer
Guideline Requirements - EU,FDA, GAMP
Vendor Evaluation Process
Risk-based Decision Making
Postal Assessment - Points to consider, when postal assessment is suitable, key points to consider during postal assessment.
Onsite Audit Assessment - Supplier Good Practices
Q&A
Vote of Thanks and contact details
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Quality Risk Management(Brief and concept) - • Quality Risk Management
Quality Risk Management ICHQ9(R1) Detailed - • Quality Risk Managemen...
How to perform cGXP Assessment for the computerized system - ua-cam.com/users/live4qmtkjcA3KM?...
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Great session
Thank you
If we make any changes in user interface or privileges we should do it csv, there is no change in hardware and sofware versions, if required how to perform csv...for particular changes or revalidation.
If we change the privilege, means we change the user access level or set the privilages, we need not do the validation. But, if we make changes in software, defintely yes.
Please share the link sir for downloa
Please check the comments section. I have shared the link in comments section.
Can i get presentation?
This session was organised long time back. So, I do not have the presentation. If you need the presentation copy for our all upcoming sessions, you can attend the LIVE sessions planned on every Saturday at 20:00 Hrs (IST). During the LIVE session, I am sharing the PPT of respective session.