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
ICT104
