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Resources

Assessments

Assessment – Investigator Snapshot

Redica Systems November 3, 2020
Conference Spotlight
The Evolving Clinical Trial Ecosystem
Jerry Chapman November 2, 2022
Blog
Quality Week 2022: A Global Celebration of Quality
Rebecca Stauffer November 7, 2022
Blog
Instant Download: Insights on Quality from FDA Leaders
Redica Systems November 8, 2022
Conference Spotlight
Is Raw FDA Data Skewing Your Analyses?

Which GMP quality system was most often linked to FDA drug recalls since 2012?  Redica’s Jerry

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Should ICH Tackle Standard Development for CGT Products?

Cell and Gene Therapy (CGT) is one of the fastest-growing areas of research and development in the

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FDA on the Evolution of Biologics Inspections: Part III

How does FDA decide whether to conduct a biologics manufacturing inspection in person or perform a remote

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Enforcement
FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer

FDA recently posted a 38-page form 483 issued to Novel Laboratories, Inc d.b.a.

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OTC Skincare Firm Receives Warning Letter Due to CGMP Concerns

December is generally a slow time when it comes to posting of FDA Warning Letters. Nevertheless, on Dec.

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FDA Warning Letters: 11/22/2020 & 12/1/2020

The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter

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Trends & Analysis
PAIs and 483 Issuance Risk: The Trends Are Not What They Seem

Did the pandemic reduce the 483 issuance risk from pre-approval inspections (PAIs)? That is how it

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Instant Download | Analysis of 2021 U.S. FDA 483 GMP Observations

A comprehensive GMP intelligence program includes monitoring health authority enforcement actions including

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Instant Download | Yes, Warehouses Must Comply with Relevant GMPs

In November 2019 FDA issued an unusual warning letter to Greenbrier International Inc (doing business as

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Webinars
Webinar – Quality Intelligence: from Information to Knowledge

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Webinar – Comparing Inspection Observations between FDA and Health Canada

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Webinar – Data Integrity and Quality Culture – Enabling far more than “just” compliance

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Reports
Report – Analysis of FDA 483s Issued to Excipient Manufacturers Since 2000

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Report – Analysis of FDA Drug GMP Warning Letters for FY2022

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Report – Breaking News: The First FDA Warning Letter to an Excipient Manufacturer

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Assessments
Assessment – Investigator Snapshot

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Assessment – Site Snapshot

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Insights

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

In Part 4 of our series on virtual agency inspections, former FDA investigator Ricki Chase provides her advice on how to host a virtual inspection, including best practices, how to adjust your logistics, and how to prepare for a closeout meeting.

Jerry Chapman July 23, 2020

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