Generate critical medical device insights with our actionable data intelligence.
We’ll help you search, analyze, and derive valuable insight from thousands of FDA, MDSAP, and Health Canada data points covering medical devices and combination products, contract manufacturers, products, inspections, and enforcement.
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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
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In this summary we identify:
FY2018-FY2020 GMP data for Lonza & Catalent
Top GMP primary citations
Top FDA 483 observations
Prepare for your next inspection.
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Prepare for your next inspection.
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Prepare for your next inspection.
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Get help choosing the right CRO.
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Compare two companies of your choice.
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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
Panel Discussion – Remote Audits
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.
Monitor compliance at your Clinical Investigator sites.
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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
Get Full Access to Redica Enforcement Analytics
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Quality Management Systems 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
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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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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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Prepare for inspections of Clinical Investigator sites.
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Compare the enforcement history of your CDMOs.
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A.I. for Quality and Compliance Teams
Presented by Redica Systems Senior GMP Quality Expert Jerry Chapman
What you will learn:
- A basic understanding of data sources, machine learning, NLP, and A.I. tools
- Building and applying Expert Models
- Two case studies, one on sterile manufacturing/503B and one on data integrity
See how we can help you eliminate yet another spreadsheet.
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Get the scoop on recent data integrity 483 observations!
- FY 2020 Data Integrity 483 Observations
- Data Integrity Observations for Human Drugs
- Observations Falling Under GMP
Human Factors – Compliance and Applications
Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and Human Factors, Kaleidoscope Innovation
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
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Keep up with the latest Regulatory Developments on Clinical Trials
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Save your team valuable time when using External Monitoring.
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Save time and Resources when using External Monitoring.
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Get immediate access to the news that matters to your sites.
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Stay ahead of changing regulations.
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Compare the inspection history of your CDMO sites.
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Upgrade your CDMO monitoring strategy.
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Upgrade your CDMO management strategy.
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Experience the Power of Redica Systems
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Upgrade your inspection strategy.
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Upgrade your inspection strategy.
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Experience the Power of Redica Systems
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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.
Evaluate Your CDMOs
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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.