Avoiding the Trap of a Data Swamp
Drug GMP Warning Letter Issued Without Facility Inspection
Unique IDs for Life Sciences Quality and Regulatory Data – Redica ID vs. FEI
At GMP by the Sea, Redica Systems Corroborates FDA Example on the Spot
Looking Outside Your Four Walls at GMP by the Sea
Welcoming Roger Angarita as Redica Systems’ New Chief Product Officer
Expert Interview: The Role of Data Operations Inside Quality and Regulatory Intelligence
Expert Interview: The CTO’s View of Quality and Regulatory Intelligence for Life Sciences
Expert Interview: How Redica Systems Serves Medtech
FDA Post-Warning Letter Meetings are Not Agency Consultations
What is “Quality and Regulatory Intelligence”?
How Redica Systems Goes Further than the FDA Data Dashboard
Audience Q&A: From Legal Considerations when Interacting with the FDA Webinar
A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Four
Legal Advice for Before, During, and After an FDA Inspection
Internal Audit Reports: Can the FDA Take a Peek? Part 2: Other Agencies
Expert Commentary | China Updates Clinical Trial Guidance on “Safety Information Assessment and Risk Management Work Procedures”
Expert Commentary | Updates to FDA’s Manual of Policies and Procedures (MAPP)
Expert Commentary: FY2022 Report on the State of Pharmaceutical Quality
A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Three
On-Demand Webinar: Insights on API Inspection Deficiencies
Peter Baker’s Roadmap to Quality Intelligence
A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Two
On-Demand Webinar: Legal Considerations when Interacting with the FDA
Redica Responds: What are Common Laboratory Inspection Findings?
A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part One
Internal Audit Reports: Can the FDA Take a Peek?
Audience Q&A: From Data Integrity and Quality Culture Webinar
Is Raw FDA Data Skewing Your Analyses?
On-Demand Webinar: Quality Intelligence: from Information to Knowledge
Beyond Data Integrity: Ulrich Köllisch on Building a Culture for Tomorrow’s High-End Data Tools
Should ICH Tackle Standard Development for CGT Products?
What Are Inferred CFR Codes?
On-Demand Webinar | Comparing Inspection Observations between FDA and Health Canada
Does Your Lab Instrumentation Adhere to Data Integrity Requirements?
FDA on the Evolution of Biologics Inspections: Part III
The “O” in ALCOA
How “Inevitable” Data Integrity Issues Cause Havoc: Part II
FDA on the Evolution of Biologics Inspections: Part II
FDA on the Evolution of Biologics Inspections: Part I
Instant Download: Insights on Quality from FDA Leaders
Quality Week 2022: A Global Celebration of Quality
On-Demand Webinar | Data Integrity and Quality Culture
The Evolving Clinical Trial Ecosystem
Persistent Non-Compliance Leads to a Consent Decree
Japan’s PMDA Formalizing Post-Approval Change System Based on Recent Pilot
Senior Management Failures Lead to Patient Deaths, Prison Sentence
Data Integrity Insights for Audit Planning