What were some of the top inspection findings by FDA and MHRA last year? What about Russia’s State Institute of Drugs and Good Practices (SID&GP) of the Ministry of Industry and Trade inspection findings? What are some of the similar inspection findings among global regulators? What about the differences?
On Thursday, Oct. 29, Redica Systems Senior GMP Quality Expert Jerry Chapman, presented, “Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019,” for a Redica Sytems webinar. His presentation was based on a session at the virtual FDA/Xavier PharmaLink conference held in March.
Download the webinar here!
What you will learn:
A comparison of 483 observations in FY2019
Top 10 findings from Russia’s State Institute of Drugs and Good Practices (SID&GP) of the Ministry of Industry and Trade
Top 10 FDA Warning Letter findings
Top MHRA inspection findings
Who Will Benefit?
Anyone responsible for regulatory inspections and who interface directly with global regulatory investigators during inspections.
About the Presenter
Jerry Chapman is a Senior GMP Quality Expert at Redica Systems. He writes the Redica Systems blog “Conference Spotlight” and is working on 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.
At Lilly and again at Elanco, Jerry designed and implemented a comprehensive GMP Intelligence process—a process to identify pertinent GMP regulations and guidance, inspection findings, trends, and best practices, then analyze, communicate, manage and archive that knowledge to help ensure the company remained compliant with GMPs and regulatory agency expectations.
Prior to joining Redica Systems, he was Chief Information Officer and Senior Editor at International Pharmaceutical Quality for six years as well as Editor in Chief for Xavier Health, covering their pharma and artificial intelligence conferences and publishing reports, primarily in Pharmaceutical Online. He was the founder and chairman of the GMP Intelligence subgroup of the Midwest Discussion Group from 2005 to 2010.
Download the webinar here!
Subscribe to Redica Insights
Get quality and compliance insights from our experts in your inbox
Get Complete Access to the Redica Systems Platform
Please submit your email address and one of our team members will contact you shortly to answer all of your questions and get you started with the new Enforcement Analytics platform.
Discover the power of the most comprehensive database of 483s in existence.
Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.
Eliminate days of work and get your FREE personalized 483 Observation Report.