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Resources

Assessments

Assessment – Investigator Snapshot

Redica Systems November 3, 2020
Blog
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
FDA Post-Warning Letter Meetings are Not Agency Consultations

After receiving an FDA warning letter, eligible generic drug firms now have the option of scheduling a

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A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Four

What are some of the product and regulatory challenges companies developing cell and gene therapy (CGT)

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A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Three

A fundamental tenet for drug product development is that a clear and deep understanding of the product is

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Enforcement
Internal Audit Reports: Can the FDA Take a Peek? Part 2: Other Agencies

In Part 1 of this article, we explored FDA’s policy on reviewing internal audit reports as outlined in

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Expert Commentary | China Updates Clinical Trial Guidance on “Safety Information Assessment and Risk Management Work Procedures”

On July 10, 2023, China’s Center for Drug Evaluation released a draft guidance for a two-week comment

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Expert Commentary | Updates to FDA’s Manual of Policies and Procedures (MAPP)

FDA Site Selection Model Updated to Include Regional Risk Factors A late-June 2023 update to FDA’s

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Trends & Analysis
How Redica Systems Goes Further than the FDA Data Dashboard

Note: The data provided in this post was gathered in July 2023.   Compared to other global

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Redica Responds: What are Common Laboratory Inspection Findings?

Redica Responds is an article series where we take common/unique questions from customers and industry

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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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Webinars
Webinar – Insights from Mapping API Inspection Deficiencies to the Quality Systems

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Webinar – Legal Considerations | Interacting with the FDA Before, During, and After Inspections

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Webinar – Quality Intelligence: from Information to Knowledge

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Reports
Report – First FDA Warning Letter to Excipient Manufacturer Provides Lessons

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Report – Intas Pharmaceuticals’ Troubles with FDA Continue

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Report – Expert Analysis: 22 years of FDA Drug GMP 483s

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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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