Prepare and Conduct Remote Audit Training Overview

This webinar explains how remote audits work, how regulatory bodies view them and some of the tools available to make the process easier. Think COVID-19 has pushed the limits in going remote? Think again, as remote audits are poised to continue after the pandemic subsides.

Now’s the time to prepare so one can stay competitive and compliant post-pandemic.

 There are various reasons for conducting remote audits which will enable Marketing Authorization Holders (MAH) to ensure that they are complying with the regulations set by various national and international health authorities. Some reasons may include:

  • Not being able to visit local company offices in countries due to security and travel restrictions (eg, Pandemics)
  • The audit entity being identified as medium or low risk following the outcome of a risk-based audit program
  • Costs of performing on -site audits, particularly for companies with little budget

As the sites where the GCP and GPV activities take place will not be visited, these audits should be designed to ensure adherence to compliance from a remote site.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Webinar Takeaway

The presentation will provide an insight and guidance to managers with QA departments to implement a Remote Auditing program, and will focus on:

  • Identifying candidates suitable for Remote Audits
  • Designing a Remote Audit program
  • Preparing and Conducting Remote Audits
  • Regulators’ attitudes toward remote audits
  • Why digitizing is the only way to perform remote audits

 Don’t get caught relying on paper in a digital, remote-audit world.

Who Will Benefit from this Remote Audit Webinar Online

  • Pharmaceutical and biotech companies
  • Medical device companies
  • Regulatory affairs professionals
  • Government affairs professionals
  • Quality unit professionals
  • Inspections and audit staff
  • Post-market safety staff
  • QSR and GMP professionals

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Michael Ramcharan Faculty

Course Instructor

Michael R 

Greater Guildford Area, United Kingdom

Michael Ramcharan has 30 years of experience in Quality Assurance having worked with multinational Pharmaceutical and Clinical Research Organisations (CRO) mainly in the GCP and GPV areas. He has conducted a wide variety of audits (both On-site and Remote) globally, and managed various risk-based audit programmes. He has also hosted and supported many European Regulatory Authority Inspections (eg; MHRA, EMA, Local EU country Inspectorates).

Michael’s audit experience has also extended to successfully designing and implementing various audit and Training programmes, and for providing general Quality Management System support. He is currently a member of the Pharmaceutical Information and Pharmacovigilance Association (PIPA), Research Quality Assurance (RQA), and an active committee member of the RQA South West, UK Regional forum group.