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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

A Glimpse into the Thought Processes of an FDA Expert Investigator

August 28, 2024
Jerry Chapman
analytical data
FDA
FDA inspection
quality systems
Simone Pitts
Enforcement

Homeopathic Product for Infants Contaminated with Bacteria and Cancer-Causing Lubricant

July 23, 2024
Jerry Chapman
contract manufacturing
drug product recall
Form 483
Inspection Issues
quality system labeling

Fine-Tuning Regulatory Compliance: A Human Performance Approach

June 12, 2024
Sarah Boynton
Biologics
CGT
human factors
Regulatory Compliance
Conference Spotlight

Blatant Data Manipulation and Password Sharing Still Taking Place

June 6, 2024
Jerry Chapman
data intelligence
Data Manipulation
Form 483

Outsourcing Partnerships — Tips for the Early Stages

June 4, 2024
Redica Systems
outsourcing
quality culture
Conference Spotlight

We Received a 483 After an FDA Inspection – Now What?

May 23, 2024
Jerry Chapman
483
483 Response Letter
EIR
FDA
Warning Letter
Conference Spotlight

Infusion Product with TNTC Bioburden Released to the Market

May 20, 2024
Jerry Chapman
bioburden
microbiological contaminant
sterility testing
TNTC
Warning Letter
Conference Spotlight

Health Canada: Regulating and Overseeing Drug and Medical Device Manufacturers

April 30, 2024
Redica Systems
Drug Manufacturing
Health Canada
HPCD
Organizational Structure
Conference Spotlight

How AI Can Reveal Enforcement Trends in Data Integrity

April 25, 2024
Jerry Chapman
artificial Intelligence
Data Integrity
Enforcement Trends
FDA
Conference Spotlight

A New Drug GMP Mutual Recognition Agreement Model

April 24, 2024
Jerry Chapman
GMP
Health Canada
MHRA
MRAs
TGA
Conference Spotlight

Antibiotic-Resistant Bacteria in Patients Is a Genetic Match to Product Contaminant

April 19, 2024
Jerry Chapman
eyedrops
FDA
Product Contaminant
UGA

Keys to Accurately Analyzing FDA’s MAUDE Database

April 12, 2024
Alison Sathe
No items found.
Conference Spotlight

Health Canada Remote/Virtual and Hybrid GMP Inspections – and Which Your Facility May Expect

April 11, 2024
Jerry Chapman
GMP
Health Canada
remote inspection
virtual inspection

Health Canada and TGA Reduce Regulatory Burden for Some Drug Company Approvals

April 9, 2024
Jerry Chapman
Drug Approvals
Health Canada

Guarding Against Risk with Vendor Agreements

March 4, 2024
Redica Systems
Quality Agreements
Supplier Agreements
Transfer of Regulatory Obligations
Vendor Agreements
vendor quality

What Is Quality Intelligence? How is Data Governance a Key Enabler?

January 16, 2024
Redica Systems
Data Governance
Data Integrity
FDA
Peter Baker
quality culture

Farewell FDAzilla.com

January 8, 2024
Redica Systems
Document Store
FDA
FDAzilla
Redica Systems

Avoiding the Trap of a Data Swamp

November 28, 2023
Jon Falker
data
Data Integrity
FDA
Intelligent document processing
Redica

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