Webinar Ask The Expert

Ask the Auditor – QA Webinar.

September 19th, 2022.

We’re holding a must-see webinar on Pharmacovigilance on September 19th with an international expert auditing panel, and ahead of this YOU, our audience, can submit other audit or inspection findings to which may be chosen for discussion.

About the webinar.

Our audit panel have selected some of the most interesting and frequent questions and findings they have found whilst in the auditing arena and are offering these for discussion.

And we’d love to hear from YOU if you have any other relevant GVP inspection or audit findings or concerns that you would like our panel to discuss also.

Our expert panel will share their deep auditing and inspection knowledge from within the PV industry to create what should be a very insightful webinar, discussing some of the most relevant topics in the industry right now, together with best practices for avoiding those frequent audit and inspection findings.

What would YOU like to ask?

This Webinar has been set up to give YOU the opportunity to shape the content and questions on frequent inspection findings, and suggest any other questions on GVP audit or inspection findings, on which you would like to ask our panel’s opinion. 

The survey will be open until August 17th, and we’re inviting you to select your top three topics for discussion, plus an option to propose your own suggestion, for panel discussion.

And what an expert panel!

We have three renowned auditors on our panel who between them have over 60 years of experience within Pharmacovigilance. 

Hosting the session will be GVP and GCP auditor Helen Lowe from Arriello, and with her will be two leading international auditors, Nazrul Khan and Michael Ramcharan, who both work on behalf of Arriello as part of our global team.

Helen Lowe

Hosting our auditing panel is Arriello’s Auditing and Quality Assurance Director. She has over 20 years’ experience within Pharmaceutical Research & Development (R&D), Quality Assurance (QA), Pharmacovigilance (PV) and clinical site auditing, Quality Management Systems (QMS), clinical drug development, post marketing drug safety / PV, and regulatory compliance. 

Helen has a proven track record of participating in and managing/hosting numerous health authority inspections, including with the FDA, BfArM, MHRA, AEMPS.

Helen Lowe Official

Michael Ramcharan

A renowned PV consultant, Michael Ramcharan has over 25 years of experience within International pharmaceutical and biotechnology companies and Contract Research Organisations (‘CROs’). 

He has a broad range of GxP knowledge and expertise including Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) and supports Arriello’s PV/Clinical Auditing and QA services across auditing, mentoring, training and more.

We are proud to have Michael as part of our expert panel of auditors. He supports Arriello’s PV/Clinical Auditing and QA services. 

MichaelRamcharan

Nazrul Khan

With over 20 years of GVP/GCP experience in pharmaceutical and biotechnology companies, Nazrul (Naz) Khan is another one of Arriello’s experienced consultants, supporting us with client projects. 

Having worked and been trained by the MHRA, Naz has an insightful view on the world of auditing from many perspectives. 

Renowned for his global PV auditing experience, we look forward to having Naz on our expert panel of auditors. 

Nazrul Khan

Where to go next – QA case studies:

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Project management, Gap analysis, Documentation
A proactive approach to passing a PV audit. Th2
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Audit support, documentation collection and preparation
Expert support delivered TH