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.
The Webinar will provide useful information on implementing policies and procedures in compliance with the applicable regulation. The risk analyses that should be considered across clinical trial systems and processes, and the tools that can be used by relevant...
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...