Thank you for such an informative video. I have a follow up question. In cases where most of the PV activities are outsourced, when vendors are monitoring their capas in their system, how would the MAH ensure oversight of the vendor capas? Would each vendor capa also be monitored in MAH quality management system? Please shed some light
Good question. You need to monitor these during your audits. Besides if the CAPA is related to the MAHs PHV activities then you need to document in the psmf as well
What is the purpose of having a separate QA for PV other than for audit and inspection preparation, when there is already a compliance function within Pharmacovigilance?
@@VigiServeAcademy after an organization makes a determination on which kpis to monitor, how is the decision documented? For example, if the organization decides to monitor kpis for deviations, where would we document our decision to monitor deviation kpis? Would we include this in the respective sop? Like state within deviation sop that deviation kpis will be monitored or would there be a separate document just speaking to all the kpis the organization has decided on monitoring? Sorry long question
You can document this in the Annex F of the psmf. If required then you can even include this in your psmf SOP where you are describing the contents of Annex F
Thanks for the quality overview presentations with case study scenarios
Great learning...
Thank you for such an informative video. I have a follow up question. In cases where most of the PV activities are outsourced, when vendors are monitoring their capas in their system, how would the MAH ensure oversight of the vendor capas? Would each vendor capa also be monitored in MAH quality management system? Please shed some light
Good question. You need to monitor these during your audits. Besides if the CAPA is related to the MAHs PHV activities then you need to document in the psmf as well
@@VigiServeAcademy Great! Thank you
You're most welcome. Also please note that you need not duplicate these CAPAs in the MAH's quality system
What is the purpose of having a separate QA for PV other than for audit and inspection preparation, when there is already a compliance function within Pharmacovigilance?
Good question. It is all about bias, as the Compliance Team reports into the PhV head while the quality team is independent
@@VigiServeAcademy thank you! What would be the specific responsibilities for each of these groups?
For compliance, you can refer to Annex F (performance indicators) of the PSMF, and for Quality, it is all that you learnt in this video.
Can you please share video on report submission/gateway?
Yes, sure - it will take some time. In the meanwhile, please check ua-cam.com/video/GJpwmroCehU/v-deo.html
Can you please give a list of all the kpis for PV QMS? Other than submission compliance.
Deviations, CAPA, safety variations, labeling updates, etc
@@VigiServeAcademy after an organization makes a determination on which kpis to monitor, how is the decision documented? For example, if the organization decides to monitor kpis for deviations, where would we document our decision to monitor deviation kpis? Would we include this in the respective sop? Like state within deviation sop that deviation kpis will be monitored or would there be a separate document just speaking to all the kpis the organization has decided on monitoring? Sorry long question
You can document this in the Annex F of the psmf. If required then you can even include this in your psmf SOP where you are describing the contents of Annex F
Sir how to apply for the pv jobs
www.linkedin.com/groups/9066932
Hi Sir, can i have your contact please?
Thank you
www.linkedin.com/in/drmanojswaminathan/