Health agencies offer guidance on rules and regulations, but it’s how they actually enforce those rules that matter. Interpreting health agency rules and regulations requires a thorough understanding of enforcement trends. This enables quality teams to gain predictive awareness and take a proactive, risk-based approach to corporate compliance, vendor quality, and site quality.
We’ve built the largest dataset of inspection and enforcement documents in the world. Then, we combined it with advanced machine intelligence delivered to you via an intuitive and easy-to-use platform. We source our data through thousands of unique Freedom of Information Act (FOIA) requests and agency monitoring tools, and our proprietary machine learning models combine industry expertise with modern data science approaches.
Redica’s Solution:
Data on all FDA inspected and registered sites since 2000, with more than 350,000 sites and 800,000 inspections.
Redica’s Solution:
Retyped, linked, and searchable documents.
Redica’s Solution:
Everything all in one place with push button reports.
Redica’s Solution:
Proprietary machine learning models.
Human Drugs
Biologics
Vaccines
Cell & Gene Therapy
HCT/P
Combo Products
Medical Device
503B Outsourcers
Homeopathic
Animal Health
Food
Cosmetics
Supplements
Herbal Products
GMP
GCP
GDP
GLP
GVP
RA-CMC
RA-Labeling
RA-Preclinical
RA-Clinical
Pharmacopoeia
Latest agency trends and hot items
Specific inspector tendencies
Benchmark to industry
Supplier research and vetting
Ongoing supplier motioning
Risk-based vs time-based audits
Audit scope improvement
Inspection management
Support for audit findings and SOPs, CAPAs, and change control
Training support
Support for audit findings
Audit scope improvement using latest agency trends
Comparisons of audit findings to agency citations
Research and vetting during study startup (CI, IRB, CRO)
Ongoing vendor monitoring
Audit scope improvement
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resources quality and safety professionals need.
Presented by Redica Systems
What you will learn:
In this summary we identify:
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In this summary we identify:
FY2018-FY2020 GMP data for Lonza & Catalent
Top GMP primary citations
Top FDA 483 observations
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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.
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:
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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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 Report:
The latest U.S. and European regulatory developments
The impact of smart combination products
How the EU MDR impacts drug-device combination products
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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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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
Presented by Redica Systems Senior GMP Quality Expert Jerry Chapman
What you will learn:
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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Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.
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