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

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Alison Sathe
Anders Vinther
Barbara W. Unger
Jackie Torfin
Jerry Chapman
Jon Falker
Katie Terry
Mark Agostino
Rebecca Stauffer
Redica Systems
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Sarah Boynton
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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
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Repeat Deficiencies in Lupin Limited Warning Letters

October 9, 2019
Redica Systems
No items found.
Conference Spotlight

FDA Expanding its Sterile Drug NIPP Inspection Pilot to Include Other Dosage Forms

September 26, 2019
Redica Systems
No items found.
Conference Spotlight

Part 2: How Amgen Uses AI Tools To Improve Manufacturing Deviation Investigations

September 18, 2019
Redica Systems
No items found.

Introducing Jonathan Rochez, Redica Systems’s New VP of Engineering

September 16, 2019
Redica Systems
No items found.
Enforcement

CTP Issues First-of-a-Kind Warning Letter to JUUL Labs

September 11, 2019
Redica Systems
No items found.
Conference Spotlight

Part 1: How Amgen Uses AI Tools To Improve Manufacturing Deviation Investigations

September 10, 2019
Redica Systems
No items found.
Trends

Identification of Software Validation Shortcomings

September 5, 2019
Redica Systems
No items found.

Gaining GMP Expertise: Govzilla Adds Jane Wastl as Senior GMP Quality Expert

August 29, 2019
Redica Systems
No items found.
Trends

Recent Statement Regarding ARB Recalls

August 29, 2019
Redica Systems
No items found.

AveXis’s New Gene Therapy Approved but New Questions Are Raised

August 14, 2019
Redica Systems
No items found.
Enforcement

Review of the Office of Generic Drugs’ 2018 Annual Report

July 25, 2019
Redica Systems
No items found.

MHRA’s “Right Environment”

July 18, 2019
Redica Systems
No items found.
Trends

Analysis of CDER Report on Pharmaceutical Quality

July 11, 2019
Redica Systems
No items found.

How Mindful Leadership Supports Data Integrity

June 27, 2019
Redica Systems
No items found.
Trends

How Small Pharma Firms Can Prepare for a GMP Inspection in 2019

June 13, 2019
Redica Systems
No items found.

Data Integrity Trends in 483s and Warning Letters: Part 3

May 30, 2019
Redica Systems
No items found.
Trends

Data Integrity Trends in 483s and Warning Letters: Part 2

May 24, 2019
Redica Systems
No items found.
Trends

Data Integrity Trends in 483s and Warning Letters: Part 1

May 16, 2019
Redica Systems
No items found.

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