Compliance


Five Steps Toward a Mature Data Integrity Culture
Five Steps Toward a Mature Data Integrity Culture
December 11, 2019

The corporate and quality culture has a significant effect on the maturity…

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Deviations: Beyond the Basics
Deviations: Beyond the Basics
June 25, 2019

There are plenty of guidelines and instructions on implementing a deviation system…

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FDA’s Top 483 Observations for 2018: A Reflection of Industry’s Compliance
FDA’s Top 483 Observations for 2018: A Reflection of Industry’s...
May 30, 2019

At the beginning of each federal fiscal year, the US FDA posts…

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7 Things to Consider in Medicinal Cannabis Development
7 Things to Consider in Medicinal Cannabis Development
February 21, 2019

Mention the word cannabis and the confusion starts; legal or illegal, nutraceutical…

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Industry Poll: How Can Your GMP Auditing Program Be Most Improved
Industry Poll: How Can Your GMP Auditing Program Be Most...
November 29, 2018

Recently, ProPharma Group conducted a poll to quality professionals across the country…

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Implementing a Risk-Based Supplier Management Program
Implementing a Risk-Based Supplier Management Program
July 10, 2018

According to recent FDA updates on the implementation of the Safety and…

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What to Expect From a FDA Inspection, Part 2
What to Expect From a FDA Inspection, Part 2
March 28, 2018

In this continuation from “Preparing for an FDA Inspection” I will discuss…

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Preparing for a FDA Inspection, Part 1
Preparing for a FDA Inspection, Part 1
March 8, 2018

  The ultimate goal of the U.S. Food and Drug Administration is…

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FDA’s Top 483 Observations for 2017: A Reflection of Industry’s Compliance
FDA’s Top 483 Observations for 2017: A Reflection of Industry’s...
January 10, 2018

At the beginning of each federal fiscal year, the US FDA posts…

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The Secret to Writing an Effective Quality Investigation
The Secret to Writing an Effective Quality Investigation
July 6, 2017

On the Blog: James Meckstroth shares his insight into developing an effective…

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Should Data Integrity Detection be a Part of Routine cGMP Training Programs?
Should Data Integrity Detection be a Part of Routine cGMP...
June 29, 2017

On the Blog: Taking a closer look at data integrity detection and…

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FDA’s Most Frequent 483 Observations for 2016: A Reflection of Industry’s Compliance
FDA’s Most Frequent 483 Observations for 2016: A Reflection of...
April 25, 2017

On the Blog: Understanding industry trends to improve your quality system.

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Understanding the 21st Century Cures Act: Part II
Understanding the 21st Century Cures Act: Part II
January 19, 2017

On the Blog: Dr. Alan Touch is continuing his series on the…

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Understanding the 21st Century Cures Act: Part I
Understanding the 21st Century Cures Act: Part I
January 5, 2017

On the Blog: Do you have questions about the impact of the…

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Investigation Best Practices
Investigation Best Practices
November 17, 2016

On the Blog: Help keep your company off the FDA Observation list…

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Problem Solving: What’s the Best Approach?
Problem Solving: What’s the Best Approach?
June 20, 2016

On the Blog: There is usually a degree of dread associated with…

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Quick Guide: cGMP for Phase 1 Investigational Drugs
Quick Guide: cGMP for Phase 1 Investigational Drugs
June 8, 2016

On the Blog: Understanding cGMP compliance for Phase I clinical trials, including…

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Value Found in FDA Warning Letter Reviews
Value Found in FDA Warning Letter Reviews
February 24, 2016

On the Blog: What can you learn from Warning Letters to help…

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FDA Inspection? Rely on Your Vendors
FDA Inspection? Rely on Your Vendors
January 20, 2016

On the Blog: When faced with questions during an FDA inspection, remember…

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FDA Issues Final Guidance on Providing Regulatory Submission in Electronic Format – The eCTD Mandate is Coming
FDA Issues Final Guidance on Providing Regulatory Submission in Electronic...
June 16, 2015

On the Blog: Are you prepared for the eCTD Mandate? Learn more…

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