Are there specific FDA GCP inspection trends that you want to monitor? How does your company monitor FDA enforcement activity involving clinical investigators? What data integrity issues are at the top of your mind?
For answers to these questions, download the Redica Systems webinar, “FDA GCP Inspection Trends Identified Using AI,” presented on June 14. Redica Systems Senior GMP Quality Expert Jerry Chapman will provide insights into FDA GCP inspection trends, including intelligence on data integrity and clinical investigator enforcement activity. This webinar was recently recorded but will feature a live Q&A.
Download this webinar recording and stay on top of the latest FDA GCP inspection trends.
What You Will Learn
- Importance and challenges of human clinical studies
- Data sources and evaluation using AI tools
- What we can learn from U.S. FDA inspections of clinical investigators
- A deeper dive into FDA Warning Letters and 483 data with some surprises
About the Expert
Jerry Chapman is a Senior GMP Quality Expert at Redica Systems. He writes the Redica Systems column “Conference Spotlight” and is working with our data engineers to build machine learning models for analysis of agency enforcement documents. He brings 40 years’ experience in the pharma industry, including 31 years at Eli Lilly in technical and leadership positions in research and product development, manufacturing, plant quality, site quality, corporate quality, and quality systems.
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