Compliance


Get the Most Out of Your GMP Effectiveness Checks
Get the Most Out of Your GMP Effectiveness Checks
July 29, 2019

We work in a highly regulated industry.  Whether you are associated with…

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

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

Read More
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…

Read More
Assumed Brexit & Batch Control Testing Site In UK
Assumed Brexit & Batch Control Testing Site In UK
March 15, 2019

The currently scheduled transition date in the Brexit process, 30 March 2019,…

Read More
Health Apps and the Requirements Imposed By the Law
Health Apps and the Requirements Imposed By the Law
March 6, 2019

If you check Apple’s App Store or Google’s Play Store you will…

Read More
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…

Read More
Outdated Facilities – Bring Back the ‘c’ in cGMP
Outdated Facilities – Bring Back the ‘c’ in cGMP
October 16, 2018

New rules, old facilities. How do these two meet? Is it a…

Read More
Industry Poll: What are the Leading Challenges with GMP Auditing?
Industry Poll: What are the Leading Challenges with GMP Auditing?
September 5, 2018

In a recent poll conducted by ProPharma Group, the question “What is…

Read More
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…

Read More
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…

Read More
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…

Read More
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…

Read More
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…

Read More
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…

Read More
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.

Read More
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…

Read More
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…

Read More
Investigation Best Practices
Investigation Best Practices
November 17, 2016

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

Read More
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…

Read More
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…

Read More
Contact Us