The presentation will provide an insight and guidance to managers with PV 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
- Tools (Questionnaires, Request for Information, Document Requests)
- Preparation Activities
- Conduct Activities
- Design, Prepare and Conduct Remote Audit in PV
- Provide tools needed to preform Remote Audits
- Using data obtained from Remote Audits to feed into the risk -based audit program
Who Will Benefit
Various representatives from Pharmaceutical and Biotech companies with responsibility as MAHs, which may include:
- QA Managers
- QA Auditors
- Qualified Persons in PV
- Heads of PV departments
Michael Ramcharan has over 25 years of experience in Quality Assurance having worked with multinational Pharmaceutical and Clinical Research Organisations since 1990. 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.
Michael 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.