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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.

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Alison Sathe
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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
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Conference Spotlight

Drug GMP Warning Letter Issued Without Facility Inspection

November 20, 2023
Jerry Chapman
CDER
FDA
PDA/FDA
Pharma

Unique IDs for Life Sciences Quality and Regulatory Data – Redica ID vs. FEI

November 16, 2023
Jon Falker
No items found.

At GMP by the Sea, Redica Systems Corroborates FDA Example on the Spot

November 8, 2023
Redica Systems
483 observations
FDA
GMP by the Sea
Quality
Redica
Conference Spotlight

Looking Outside Your Four Walls at GMP by the Sea

November 1, 2023
Redica Systems
483 observations
Form 483
GMP by the Sea
quality management systems

Welcoming Roger Angarita as Redica Systems’ New Chief Product Officer

October 18, 2023
Redica Systems
CPO
Redica Systems
Roger Angarita

Expert Interview: The Role of Data Operations Inside Quality and Regulatory Intelligence

October 11, 2023
Jon Falker
Data Enrichment
Data Operations
Expert Interview
Redica Systems

Expert Interview: The CTO’s View of Quality and Regulatory Intelligence for Life Sciences

October 10, 2023
Jon Falker
No items found.

Expert Interview: How Redica Systems Serves Medtech

October 6, 2023
Jon Falker
Expert Interview
Medtech
Redica Systems
Conference Spotlight

FDA Post-Warning Letter Meetings are Not Agency Consultations

September 25, 2023
Jerry Chapman
FDA
Guidance
PDA
Pharma
Post Inspection

What is “Quality and Regulatory Intelligence”?

September 11, 2023
Redica Systems
data
QRI
Regulatory Surveillance
Trends

How Redica Systems Goes Further than the FDA Data Dashboard

August 21, 2023
Redica Systems
Comparison report
data
FDA
FDA Dashboard
Redica

Audience Q&A: From Legal Considerations when Interacting with the FDA Webinar

August 10, 2023
Redica Systems
FDA
inspection preparation
Law
Legal Advice
Pharma
Conference Spotlight

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Four

August 2, 2023
Jerry Chapman
No items found.

Legal Advice for Before, During, and After an FDA Inspection

July 25, 2023
Redica Systems
Data Ingegrity
FDA
GMP
Inspections
Legal Advice
Enforcement

Internal Audit Reports: Can the FDA Take a Peek? Part 2: Other Agencies

July 18, 2023
Jerry Chapman
FDA
Internal Audits
Pharma
Supplier audits
Swissmedic
Enforcement

Expert Commentary | China Updates Clinical Trial Guidance on “Safety Information Assessment and Risk Management Work Procedures”

July 13, 2023
Jerry Chapman
China
Clinical Trial Guidance
Enforcement

Expert Commentary | Updates to FDA’s Manual of Policies and Procedures (MAPP)

July 12, 2023
Jerry Chapman
CDER
FDA
MAPP
Pharma
Policy
Enforcement

Expert Commentary: FY2022 Report on the State of Pharmaceutical Quality

June 29, 2023
Redica Systems
483
FDA
GMP
Report
Warning Letter

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