Conference Spotlight

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

Open filters
Search
Tags
Author
Alison Sathe
Anders Vinther
Barbara W. Unger
Jackie Torfin
Jerry Chapman
Jon Falker
Katie Terry
Mark Agostino
Rebecca Stauffer
Redica Systems
Roger Angarita
Sarah Boynton
Scott Sherrill
Subscribe to our Newsletter
Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
Subscribe
Conference Spotlight

How Would FDA Grade Your Site? The Quality Metrics Feedback Program

August 13, 2020
Redica Systems
No items found.
Conference Spotlight

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

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

Part 2: Department of Justice Consumer Protection Branch Doubles in Size to Battle Fraud and Deception in the Drug and Dietary Supplement Industries

February 25, 2020
Redica Systems
No items found.
Conference Spotlight

How to Talk So That FDA Will Listen, and How to Listen When They Talk: Advice That Could Be Worth Millions

January 10, 2020
Redica Systems
No items found.
Conference Spotlight

How Key Pharma and Device Executives Are Developing the Next Generation of Quality Professionals and Leaders

November 6, 2019
Redica Systems
No items found.
Conference Spotlight

Office of Combination Products Official Details Rulemaking and Guidance Agenda

October 17, 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.
Conference Spotlight

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

September 10, 2019
Redica Systems
No items found.

Other Resources