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

CMC Challenges and Opportunities in Latin America

September 13, 2022
Jerry Chapman
CMC
Drug Approval
Latin America
Pharma
Conference Spotlight

An FDA Perspective on Decentralized Clinical Trials: Part III

August 11, 2022
Jerry Chapman
clinical trials
FDA
Conference Spotlight

An FDA Perspective on Decentralized Clinical Trials: Part II

August 4, 2022
Jerry Chapman
ALCOA
Anne Johnson
Data Integrity
DCT
decentralized clinical trials
Conference Spotlight

An FDA Perspective on Decentralized Clinical Trials: Part I

July 28, 2022
Jerry Chapman
Anne Johnson
BIMO
clinical trials
DCT
decentralized clinical trials
Conference Spotlight

From Data Integrity to Data Culture

July 21, 2022
Rebecca Stauffer
2022 PDA Annual Meeting
clinical research organization
CROs
data culture
Data Ingegrity
Conference Spotlight

Five FDA Warning Letters Issued in Four Years for Fraudulent Cancer Drug

July 14, 2022
Jerry Chapman
BIMO
CDER
clinical hold
clinical trial monitor
clinical trial sponsor
Conference Spotlight

Extracting Specific Protocol Violations from Warning Letter Citations

June 23, 2022
Jerry Chapman
No items found.
Conference Spotlight

FDA Issues First Notices of Noncompliance on ClinicalTrials.Gov

June 16, 2022
Jerry Chapman
clinical trial sponsor
clinical trials
GCP
NIH
RA-Clinical
Conference Spotlight

Instant Download | 4 GMP Case Studies

June 15, 2022
Redica Systems
No items found.
Conference Spotlight

The Components of “Responsibilities of the Investigator” Observations

June 9, 2022
Jerry Chapman
483
clinical investigator
GCP
Jerry Chapman
SQA
Conference Spotlight

Perforated Tables in Cleanrooms Draw FDA Attention

June 2, 2022
Jerry Chapman
case studies
cleanroom
FDA
FDA inspection
GMP
Conference Spotlight

Data Integrity and Your Clinical Investigator: What the Data Shows

May 26, 2022
Jerry Chapman
483
Data Integrity
FDA
GCP
gcp inspections
Conference Spotlight

Discolored HEPA Filters Recolored by Sterile Manufacturer

May 24, 2022
Jerry Chapman
case studies
deviation investigations
equipment cleaning
GMP
HEPA filter
Conference Spotlight

Inadequate Equipment Cleaning Leads to Cross Contamination, FDA Warnings

May 17, 2022
Jerry Chapman
case studies
cleaning validation
Contamination
GMP inspection
inspection prep
Conference Spotlight

Change Management Failures Documented in FDA Warning Letter

May 10, 2022
Jerry Chapman
case studies
change control
FDA
GMP inspections
inspection trends
Conference Spotlight

Is Your Quality System Up to Par for Your Next FDA Inspection?

March 10, 2022
Redica Systems
No items found.
Conference Spotlight

How One Pharma Firm Ensures Robust GMP CAPA Effectiveness at CMOs

March 3, 2022
Redica Systems
No items found.
Conference Spotlight

UDI Compliance for Medical Devices: Part II

February 9, 2022
Redica Systems
No items found.

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