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Meena Garg

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Canada

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1 to 5 of 27 total

CDMO manufacturing biologic material for clinical trial Phase 1 and 2

Posted By Meena Garg 28-Sep-2023 15:41
Found In Egroup: Regulatory Open Forum \ view thread
Can anyone please comment on Drug substance and intermediate drug product manufacturing by a CDMO-what are the requirements for 1) sample retention and 2) Records retention for the CDMO as the supplier of the clinical material?

RE: Should Job descriptions and Organizational charts be controlled ?

Posted By Meena Garg 27-Sep-2023 16:04
Found In Egroup: Regulatory Open Forum \ view thread
To add to all great points posted by RAPS colleagues: "Controlling job descriptions" also means that job descriptions should be approved by Functional Area Management and HR and signed off by the employee when accepting the role. This combined with employee training record provides documented evidence ...

RE: Phase 1 Clinical Trials

Posted By Meena Garg 07-Mar-2023 08:57
Found In Egroup: Regulatory Open Forum \ view thread
Biologics Sent from my iPhone

RE: Phase 1 Clinical Trials

Posted By Meena Garg 07-Mar-2023 07:10
Found In Egroup: Regulatory Open Forum \ view thread
Thank you for your replies.. The question is for GMO ( not GMP) certificates. Are these equivalent to Animal Origin Certificates for raw materials but specific for CGT products? Sent from my iPhone

Phase 1 Clinical Trials

Posted By Meena Garg 04-Mar-2023 06:39
Found In Egroup: Regulatory Open Forum \ view thread
Can anyone guide if Health Canada requires a GMO certificate for a Phase 1 clinical submission? Thank you Sent from my iPhone