A14 – Implementing new process validation guidelines

Both the EU and US have published new requirements for Process Validation.  PIC/S are soon to adopt similar guidance.  These new guidelines bring a requirement for clearer linkages to development activities and require continuous process monitoring.  This session will:

  • Introduce the new PV requirements and their genesis
  • Discuss the likely impact to Australian sponsors
  • Provide case studies for how local manufacturers are gearing up to meet these requirements

Chairperson: Ben Saur, ISPE Director and Global Medical Solutions