Blog

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

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

Desk Inspections, Missed Action Dates Take Place of FDA In-Person Site Visits

February 25, 2021
Redica Systems
No items found.
Enforcement

FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer

February 23, 2021
Redica Systems
No items found.
Conference Spotlight

FDA Chooses Not to Perform Virtual Inspections in Contrast with Non-U.S. Agencies

February 18, 2021
Redica Systems
No items found.

(Video) A 21st Century Solution for Regulated Industries

February 16, 2021
Redica Systems
No items found.
Conference Spotlight

Impact of the EU MDR on Combination Product Sale and Registration in the EU

February 11, 2021
Redica Systems
No items found.

Surveying the Smart Combination Product Ecosystem

February 9, 2021
Redica Systems
No items found.
Conference Spotlight

Case Study of Contaminated WFI in China

February 3, 2021
Jerry Chapman
China
GMP
pharmaceutical water
Quality
Small Pharma

An Analysis of 2015 to 2019 FDA 483 Data

January 28, 2021
Redica Systems
No items found.

What is Enforcement Analytics?

January 26, 2021
Redica Systems
No items found.
Conference Spotlight

EU Animal Health Legislation Aims to Reduce Industry Burden

January 21, 2021
Redica Systems
No items found.
Conference Spotlight

Russian Inspectorate Weighs in on Remote Audits and International Harmonization

January 20, 2021
Redica Systems
No items found.
Conference Spotlight

FDA Combination Products Policy and Guidance Changes

January 14, 2021
Redica Systems
No items found.
Enforcement

OTC Skincare Firm Receives Warning Letter Due to CGMP Concerns

January 13, 2021
Redica Systems
No items found.

New Year, New Enforcement Analytics

January 7, 2021
Redica Systems
No items found.
Conference Spotlight

FDA OMQ Regulatory Actions Increase Dramatically in FY2020

January 5, 2021
Redica Systems
No items found.

Our Top 5 Webinars of 2020

December 30, 2020
Redica Systems
No items found.

Our Top 5 Articles of 2020

December 29, 2020
Redica Systems
No items found.

Overcoming CMC Complexity for Cell & Gene Products

December 24, 2020
Redica Systems
No items found.

Other Resources

Assessments

Insights on inspections, risk and compliance

Reports

Benchmark industry trends and best practices

Webinars

Hear from industry leaders and Redica experts.