In a six-year collection of FDA warning letters issued to clinical investigators (CIs) of human studies,
In 2021, FDA issued its first three official notices of noncompliance on the clinicaltrials.gov website for
With 483s from a key set of human clinical study inspections, we used the Redica Systems Expert Model for
FDA recently posted a 38-page form 483 issued to Novel Laboratories, Inc d.b.a. LUPIN, located in
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
A comprehensive GMP intelligence program includes monitoring health authority enforcement actions including
In November 2019 FDA issued an unusual warning letter to Greenbrier International Inc (doing business as
It has been an interesting two years, to say the least! We have seen unprecedented upheaval in FDA
Presented by Jerry Chapman on October 29, 2020
What you will learn:
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INDEX INFORMATION Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.
STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.
ANALYZE & INTERPRET PATTERNS Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.
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In this summary we identify:
In this summary we identify:
FY2018-FY2020 GMP data for Lonza & Catalent
Top GMP primary citations
Top FDA 483 observations
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.
Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble
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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:
SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.
WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject
SITES Quickly assess inspection records including dates and inspectors across all of your sites
INSPECTIONS Complete list of FDA inspections by date, company, category, and country
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Presented by Steve Greer on June 23, 2020
What you will learn:
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
What You Will Learn from This Report:
How a major pharmaceutical company designed a program to train future leaders in quality
An industry-led initiative to advance the state of quality in the pharma industry
A pharma GMP leader’s tips for supporting quality culture within an organization
An update on FDA’s Quality Maturity Model
Presented by Paul Smith, Agilent Technologies on Aug. 26, 2020
What you will learn:
Presented by Regulatory Compliance Associates Distinguished Fellow Susan Schniepp
What you will learn:
Presented by Redica Systems
What you will learn:
What You Will Learn from This Report:
The latest U.S. and European regulatory developments
The impact of smart combination products
How the EU MDR impacts drug-device combination products
What You Will Learn from This Report:
In-depth analysis of the findings
Lessons learned
How companies can avoid similar shortcomings.
Index Information Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.
Strengthen Datasets Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.
Analyze & Interpret Patterns Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.
What You Will Learn from This Sample:
See how a 510(k) submission is structured
Find out what information to include
Review correspondence between sponsor and FDA
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Presented by Redica Systems Senior GMP Quality Expert Jerry Chapman
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Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and Human Factors, Kaleidoscope Innovation
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