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

On-Demand Webinar: Insights on API Inspection Deficiencies

June 6, 2023
Redica Systems
No items found.

Peter Baker’s Roadmap to Quality Intelligence

June 1, 2023
Redica Systems
Data integirty
Inspections
Pharma
Quality
Quality Intelligence
Conference Spotlight

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

May 25, 2023
Jerry Chapman
Cell and Gene
FDA
GMP
Inspections
Pharma

On-Demand Webinar: Legal Considerations when Interacting with the FDA

May 9, 2023
Redica Systems
No items found.
Trends

Redica Responds: What are Common Laboratory Inspection Findings?

May 1, 2023
Redica Systems
483
Inspections
laboratory
Quality
Conference Spotlight

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

April 27, 2023
Jerry Chapman
Cell and Gene
CGT
Quality
Enforcement

Internal Audit Reports: Can the FDA Take a Peek?

April 19, 2023
Jerry Chapman
FDA
GMP
Internal Audits
Pharma
Quality

Audience Q&A: From Data Integrity and Quality Culture Webinar

April 3, 2023
Redica Systems
No items found.
Conference Spotlight

Is Raw FDA Data Skewing Your Analyses?

March 23, 2023
Redica Systems
Drug recalls
GMP
Pharma
Quality
quality systems

On-Demand Webinar: Quality Intelligence: from Information to Knowledge

March 21, 2023
Redica Systems
No items found.

Beyond Data Integrity: Ulrich Köllisch on Building a Culture for Tomorrow’s High-End Data Tools

March 14, 2023
Redica Systems
483
Data Integrity
GMP
Quality

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