Remote Auditing – Effective Implementation

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. 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

Areas Covered in the Session :

• Definitions of Remote Audits
• Identifying Remote Audit Candidates
• Preparing Remote Audits
• Conducting Remote Audits
• Remote Audit Experiences

Who Should Attend:

Various representatives from Pharmaceutical and Biotech companies with responsibility as MAHs, which may include:

• Quality Assurance Managers
• Quality Assurance Auditors
• Clinical Quality Control/Assurance Professionals
• Qualified Persons in PV
• Clinical Research Associates
• Heads of PV Departments
• Compliance and Regulatory Managers

Course Director: MICHAEL RAMCHARAN

Michael Ramcharan (BSc, MSc, MRQA) has nearly 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 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 GPV 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 prioritize 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.