Conference Spotlight

Key takeaways, industry discussions, and insights from major regulatory conferences.

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Alison Sathe
Anders Vinther
Barbara W. Unger
Jackie Torfin
Jerry Chapman
Jon Falker
Katie Terry
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Rebecca Stauffer
Redica Systems
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Conference Spotlight

FDA: A Pillar of Protection for Patients and Industry

April 4, 2025
Jerry Chapman
FDA
FDA Oversight
Patient Safety
Conference Spotlight

Facility Issues Top Inspection Deficiencies for Biologics

November 12, 2024
Jerry Chapman
BLAs
CDER
OPMA
OPQ
PDA/FDA
Conference Spotlight

Who is Responsible When GMPs Are Not Followed?

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

What is a VAI or OAI Regulatory Meeting?

October 2, 2024
Jerry Chapman
CDER
CGMP
DOJ
FDA
Guidance
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
Conference Spotlight

Blatant Data Manipulation and Password Sharing Still Taking Place

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

Drug GMP Warning Letter Issued Without Facility Inspection

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

FDA Post-Warning Letter Meetings are Not Agency Consultations

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

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

August 2, 2023
Jerry Chapman
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