The current COVID-19 pandemic has a considerable impact on citizens, patients and businesses. It may force marketing authorization holders of medicinal products and regulatory authorities to operate under business continuity mode, impacting the standard way of working. Moreover, public health needs may require quick actions or re-prioritization of operations.
This webinar provides guidance to marketing authorization holders of medicinal products for human use (“MAH”) on regulatory expectations and flexibility during the COVID-19 pandemic.
Areas Covered in the Session :
- What are Regulators saying ?
- What are Remote Audits?
- Why Remote Audits?
- What is Risk of Remote Audits?
- What are opportunities of Remote Audits?
- What all companies are eligible for Remote Audit?
- What are requirements for Remote Surveillance or Recertification Audits?
- Coming into Force
- Planning and Preparing for audit
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- GMP Auditors from Pharmaceutical / API