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

ICH Q9 Quality Risk Management in Pharma

October 15, 2024
Redica Systems
ICH
ICH Q9
Pharma
QRM
Quality Risk Management
Enforcement

FDA Inspection Shows Systemic Data Falsification Issues

October 11, 2024
Jerry Chapman
483
API
API Manufacturer
Data Falsification
Conference Spotlight

Who is Responsible When GMPs Are Not Followed?

October 9, 2024
Jerry Chapman
CDER
CDER Updates
CDMO
CMO
Contract Facilities
Enforcement

Comprehensive Guide to 21 CFR 820.30 for MedTech

October 8, 2024
Redica Systems
483 observations
ALCOA
consent decree
EMA
FDA
Conference Spotlight

What is a VAI or OAI Regulatory Meeting?

October 2, 2024
Jerry Chapman
CDER
CGMP
DOJ
FDA
Guidance

Introducing PostMarket Intelligence for MedTech Companies

September 30, 2024
Redica Systems
adverst event
LMS
Medtech
Postmarket Intelligence
postmarket surveillance
Conference Spotlight

FDA Investigator Attrition Rate Addressed at 2024 PDA/FDA Conference

September 11, 2024
Jerry Chapman
FDA
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

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