Reumat Consulting Remote Auditing (GCP and GVP) Webinar in association with Research Quality Assurance (RQA: www.therqa.com).
Background:
There are various reasons for conducting remote audits, which will enable Marketing Authorisation 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 (e.g. pandemics) - The audit entity being identified as medium or low risk following the outcome of a risk-based audit programme - 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.
The presentation will provide an insight and guidance to managers with QA Departments to implement a Remote Auditing programme, and will focus on:
- Identifying candidates suitable for Remote Audits - Designing a Remote Audit programme - Preparing and Conducting Remote Audits.
The following topics will be covered:
- Definitions of Remote Audits - Identifying Remote Audit Candidates - Preparing Remote Audits - Conducting Remote Audits - Remote Audit Experiences.
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