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What to Expect When You’re Inspected


Overview

Pharmaceutical and medical devices companies are frequently inspected by the authorities as a central element of supervision. Successfully completing a GMP regulatory inspection is critical to operations and commercial success of a company; this cannot be accomplished without proper preparation and management since proper inspection management techniques have to be used to mitigate the risk of receiving an observation for compliance gaps. This session will provide insight on understanding the most common regulatory agencies expectations and will discuss how to prepare for and manage the actual inspection and describe follow-up activities required for close-out, as well as real-life lessons learned through being involved and conducting audits.

Featured topics

  • Clinical Safety and Pharmacovigilance
  • Regulatory Affairs
  • Who should attend?

    Professionals who work in the area of:
    • Clinical Data Management/eClinical
    • Comparative Effectiveness/Health Technology Assessment
    • Clinical Safety/Pharmacovigilance
    • Clinical Research
    • Document Management/eSubmissions
    • Medical Communications
    • Outsourcing
    • Project Management
    • Public Policy/Law/Corp. Compliance
    • Quality Assurance, Control
    • Regulatory Affairs
    • Research & Development
    • Statistics

    Learning objectives

    At the conclusion of this webinar, participants should be able to:
    • Understand the most common regulatory agencies expectations in respect to pharma and medical devices audits and inspections
    • Prepare for and manage inspections, to ensure a successful inspection outcome when they have limited experience in this activity and limited resources

    Contact us

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    1.888.257.6457
    +1.215.442.6100


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    +1.215.442.6194