Navitas Life Sciences

Getting Inspection Ready

Hosted by Navitas’ pvindia Network, and presented by Louise Jebson, Head of Networks at Navitas Life Sciences and Jean-Christophe Delumeau, Head of Pharmacovigilance China and Asia Pacific at Bayer HealthCare, this webcast will explore the topic of ‘Getting Inspection Ready’. Staying abreast of what regulatory authorities require can be difficult to achieve. Success or failure of an inspection from a regulatory authority is determined by both practice and preparation. This webinar highlights the obstacles and pitfalls, strategy design, together with making inspection management a priority.

  • Latest Regulatory Context
    • Global trends and context
    • Emerging Indian regulations
  • A case study approach to Audits and Inspections - Bayer HealthCare
  • 5 Steps to Inspection Readiness
    • An integrated approach and mindset
    • PSMF – core and local
    • Governance and roles
    • Compliance metrics and KPIs
    • Managing CAPAs
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