After the United Kingdom officially left the European Union at the end of 2020—the so-called Brexit
Is your company’s quality management system (QMS) proactive or reactive? Does your company use data,
The pharmaceutical industry has been criticized for being slow to adopt new technology, with a tendency to
FDA recently posted a 38-page form 483 issued to Novel Laboratories, Inc d.b.a.
December is generally a slow time when it comes to posting of FDA Warning Letters. Nevertheless, on Dec.
The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter
[Editor's Note: This post has been updated; originally published on June 13, 2019.] Preparing for GMP
[Editor's Note: This is Part II of an analysis of the FY2019 UK MHRA GMP deficiencies by Redica Systems
[Editor's Note: Below is Part I of an analysis of the U.K. MHRA GMP deficiencies for 2019. Part II will
What You Will Learn from This Report:
The first countrywide import alert issued by FDA
An inadequate deviation investigation
An inadequate product specifications and a product recall
Process validation issues at a CMO
A different perspective on process validation and the culpability of the quality unit
In this summary we identify:
FY2018-FY2020 GMP data for Lonza & Catalent
Top GMP primary citations
Top FDA 483 observations
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In this summary we identify:
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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Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble
What you will learn:
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Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate
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What you will learn:
In this summary we identify:
GMP data from FY2017 to FY2020 for the Asia-Pacific region
Top 3 GMP primary and secondary citations
In this summary we identify:
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Presented by Redica Systems Senior GMP Quality Expert Jerry Chapman
What you will learn:
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Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and Human Factors, Kaleidoscope Innovation
What you will learn:
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