This allows your team to keep stakeholders proactively informed and ensure nothing critical is missed.
A critical differentiator in our External Monitoring solution is the combination of Redica’s industry-leading technology and automation with oversight and direct access to some of the best minds in the industry.
Senior GMP Quality Expert
Led Amgen’s Corporate GMP Audit group focused on API manufacturers, Quality Systems, and Computers. Developed, implemented, and maintained the GMP Regulatory Intelligence program for 8 years.
Senior GMP Quality Expert
Designed and implemented Eli Lilly’s comprehensive GMP intelligence process to identify, analyze, and archive pertinent drug GMP regulations, inspection findings, trend discovery, and best practices.
GMP/Medical Device/Combo Products Expert
Experience in quality assurance, supplier quality, and regulatory affairs.
GCP Expert
Experience in statistics, validation, audits, monitoring, validated SAS program development, GLP & GCP system evaluation, P&P writing, and set new standards for communicating audit findings.
Senior GMP Quality Expert
Served in Eli Lilly leadership and technical positions in site and corporate quality assurance, quality control laboratory, training, master scheduling, capacity planning, and six sigma.
We configure our tools to your unique monitoring objectives and data requirements. Our dynamic design capabilities ensure each user can quickly find, review, and assess critical information based on their functional area.
Traditional regulatory intelligence approaches are resource-intensive and still often miss risk signals and emerging trends. External Monitoring takes regulatory intelligence out of your hands via automated updates and regular communication about regulatory changes.
Monitoring communication includes links for drill-down research while additional analysis opportunities are available for users with the Enforcement Analytics Module.
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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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