Expert Insights Webinars:

Insights and Trends from 2021 FDA GCP Inspections

What You Will Learn

The FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations. Reviewing inspection observations and trends from 2021 can help clinical researchers determine common issues, highlight potential quality management gaps and identify improvement opportunities.

Key Takeaways

In this Expert Insights webinar, you'll learn how to improve your quality systems and increase compliance as we will review FDA observations and trends from 2021 on:
  • 483 Observations
  • Warning Letters
  • Seizures
  • Trends & the R3 Draft

Speaker

MMS Webinar Speaker_Melissa Sullivan-01-1

Melissa Sullivan is a Senior Quality and Compliance Specialist with 17 years of experience in the pharmaceutical and quality industry, specializing in Good Clinical Practice (GCP) with experience in Good Laboratory Practice. She is an expert in planning, preparing, and conducting audits in various GxP areas and maintains a strong understanding of compliance regulations and guidance.

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