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!

On-Demand Webinar | Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

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!

On-Demand Webinar | Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

 

Human Factors – Compliance and Applications

June webinar

Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and  Human Factors, Kaleidoscope Innovation 

June 29, 1:30 p.m. EST

What you will learn:

  • Human factors strategies from simple drug products to complex surgical devices
  • Primary and secondary labeling development and evaluation for usability
  • Human factors activities from product development to post-market
  • International strategies: expectations for human factors in regulatory submissions in international markets

Panel Discussion – Remote Audits

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Featuring Panelists:
—Barbara W. Unger, Unger Consulting, Inc.
—Jerry Chapman, Redica Systems
—Stephanie Gaulding, Pharmatech Associates

Who Will Benefit?
This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.

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Download your copy of THE FDA INSPECTION LANDSCAPE IN MID-2020 AND A LOOK AT VIRTUAL INSPECTION

In this summary we identify:

  • Trend analysis of FDA inspections through mid-2020
  • Strategies for preparing and hosting virtual inspections
  • New technologies to support remote inspections

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In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

Turning Failure into Success

Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble

What you will learn:

  • How to use the Leadership SOS Model to transform quality culture
  • How to strengthen quality systems to eliminate human error
  • How to generate ideas on how to set your organization up for success for shareholders, FDA, and staff
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Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

Get instant access to the webinar video and slides.

What you will learn:

  • Common challenges small pharma firms face when developing a QMS
    Recent enforcement trends involving the Quality Unit
    Impact of the COVID-19 pandemic

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In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

Download the Special Report

An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

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