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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.
Michael Ramcharan (BSc, MSc, MRQA) has nearly 30 years of experience in Quality Assurance having worked with multinational Pharmaceutical and Clinical Research Organisations. His auditing experience has involved conducting a wide variety of audits (On-site and Remote) in GPVP, GCP and GCLP, globally. He has also hosted and supported various Regulatory Authority Inspections (eg, MHRA, EMA, Local EU) in the GCP and GPVP space.
Michael’s audit experience has also extended to successfully designing, implementing, and conducting Remote Audits in the GPVP arena which has allowed companies to maintain strong oversight of their Local Operating Companies and Business Partners in countries where travel restrictions do not allow for on-site audit visits. He has also assisted companies in managing their Pharmacovigilance QA audit programs adopting a risk-based approach to help identify and prioritise audits.
Michael has also been involved in the Training and Mentoring of auditors, providing bespoke training catered specifically to an individual’s development needs, and his varied experience has proved very valuable in this area.