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

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Aditi Singhai
Alison Sathe
Anders Vinther
Anne-Caroline Boillot
Barbara W. Unger
Barry Price
Jackie Torfin
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Jon Falker
Katie Terry
Khushboo Agrawal
Mark Agostino
Michael de la Torre
Rebecca Stauffer
Redica Systems
Roger Angarita
Sarah Boynton
Scott Sherrill
Tashil Sharma
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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
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Conference Spotlight

Preparing for a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase

July 16, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week of 07/05/20: Supplier Qualification

July 14, 2020
Redica Systems
No items found.
Conference Spotlight

A State-of-the-Art Virtual Inspection Methodology Using Mixed Reality Technology Gets High Marks from European Medicines Agency Inspector

July 9, 2020
Redica Systems
No items found.
Enforcement

Warning Letters 06/28/20: Unapproved Vendors

July 7, 2020
Redica Systems
No items found.
Conference Spotlight

Yes, FDA is Still Performing Pharma Inspections, Using Risk-Based Criteria: What is Your Risk for Inspection?

July 2, 2020
Redica Systems
No items found.
Enforcement

FDA Warning Letters Week of 06/21/20: For-Cause Inspection & Untitled Letter From A 2018 Inspection

June 30, 2020
Redica Systems
No items found.
Conference Spotlight

Microbiological Issues with Aseptic Processing and Lyophilization: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

June 25, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week of 06/14/20: Data Integrity

June 23, 2020
Redica Systems
No items found.
Conference Spotlight

Inadequate Media Fills at a Sterile Manufacturer When Starting up After a Shutdown: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

June 18, 2020
Redica Systems
No items found.
Conference Spotlight

Cleaning and Cross-contamination Issues with an Encapsulator: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

June 11, 2020
Redica Systems
No items found.
Conference Spotlight

David Doleski Encourages Industry to Participate in FDA’s Emerging Technology Efforts; Sanofi Case Study Reviewed

June 9, 2020
Redica Systems
No items found.
Trends

What is Risk-Based Thinking?

June 4, 2020
Redica Systems
No items found.
Enforcement

FDA Warning Letters Week of 05/24/20: Sterile Drugs, OTC Products, & Hiring of Quality Consultants

June 2, 2020
Redica Systems
No items found.
Conference Spotlight

Former FDA Official David Doleski on Agency Hot Button Issues and Developing a Positive Relationship

May 28, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week of 5/17/20

May 26, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week of 5/3/2020: 42 Concern COVID-19 Claims

May 12, 2020
Redica Systems
No items found.
Conference Spotlight

Avoiding and Reacting to Human Tissue, Cell, and Gene Therapy Enforcement Actions: Communication is Key

May 7, 2020
Redica Systems
No items found.
Enforcement

FDA Warning Letters Week of 4/27/2020: HCT/P

May 6, 2020
Redica Systems
No items found.

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