GAP Analysis and Remediation in Pharmaceuticals

#dataintegrity #datagovernance #pharmaceutical #quality #fda #MHRA #msdeskillindia #nsdl
Many organizations are getting critical observations from regulators. Even the manufacturing licenses are suspended for many pharmaceuticals.
The companies failed to evaluate the GAPS in their own working areas. Here, will discuss the GAPS identification and remediation.
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[@hitendrakumarshah3718]

Dear all, You can download the training presentation from the link below. Kindly note that the link may be valid only up to March 06,2024. So download as early as possible. Link: we.tl/t-PZDHR5181k

[@KoradaNageshnagesh]

Hi Sir, Could you make a presentation on GAMP5 edition2

[@hitendrakumarshah3718]

I need to get edition 2. Once I get it, will prepare on it.

[@udayavasamsetti2554]

Dear sir, please share the link for downloading the presentation

[@hitendrakumarshah3718]

I do not have presentation after the training. During LIVE training, I am sharing the link. I suggest for future training, you can attend all LIVE session for presentation copy.

[@gangadharveeramallu3910]

Sir plz share the link for downloading the presentation

[@hitendrakumarshah3718]

Hi, I have shared during the LIVE session. Hope you attended the LIVE session.

[@sarathbabu2293]

Hii sir
In xxx product to additionally utilise the reactor ( All parameters are match with existing reactor except capacity is different) in that case how to perform impact assessment to change control procedure.
Kindly guide me sir

[@hitendrakumarshah3718]

Hi, I need to evaluate all the details for example, make, model, operating principle, MOC, controls etc. Then only I can guide you.