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Entries by Ashley Farley

PDA New England Chapter Inspection Trends Event

ICQ will be participating as a sponsor at the next PDA meeting, “Regulatory Inspection Trends”.  Please stop by and visit our table and say hello.  The event features presentations by Edmund Mrak, David Sencabaugh and William Frisch and will run from 5:30 – 9:00 PM.  This event takes place on November 18, 2015 at the […]

Rouge Corrosion in High Purity Systems

It can be disheartening to design and build a new pharmaceutical facility with shiny new stainless steel process vessels and tubing only to see what appears to be rust appearing exactly where you don’t want it. However there is hope and you are not alone. Rouging in process equipment is very common and in some […]

The Importance of Donating Your Time

In, 2014 there were over 610,000 homeless men, women and children in the United States and another 45 million people, that’s 15% of the total U.S. population, living below the poverty line. These statistics demonstrate a need for help, a need for volunteers to make a difference and support those that are disadvantaged.  Volunteering has […]

Method Transfer

Method transfer is a regulatory requirement that is performed between two sites. It is a documented process to verify a certain laboratory’s capability of performing the analytical testing method’s intended use. Method transfers are performed for validated methods for which complete analytical methods and validation data are available. Method transfer between laboratories and different company […]

Laughter, the Shortest Form of Meditation

Laughter, humor and smiling in the workplace can have a tremendously positive affect on a company’s culture. The use of humor, and the ability to produce and make humor, is associated with intelligence and creativity – two things highly valued in the workplace. Smiling and laughter are free! They boost health, mood, longevity and success. […]

A little about Cleaning Validation…

Cleaning Validation (CV) is driven by regulatory expectations to ensure that residues from one product will not carry over and cross contaminate the next product. Regulatory scrutiny is more rigorous in a multi-product facility compared to a single product establishment. Companies are usually cited either for not having a sound cleaning validation or not meeting […]

Season’s Greetings!

Everyone here at ICQ Consultants would like to wish our employees and colleagues a very happy holiday season and new year.  Thank you, everyone, for your hard work and dedication.  We appreciate all you do to assist in the success of our company.  We have had the pleasure to work with a multitude of outstanding […]

ICQ Consultants, Engineering Better Solutions

  Integrated Commissioning & Qualification Corporation (ICQ) is a leading provider of commissioning, qualification and verification services to companies in the life sciences and pharmaceutical industries. We develop programs and procedures that promote, facilitate and ensure compliance with stringent regulatory standards and our clients’ own internal quality standards. During our history, teams of ICQ consultants […]

The Process Validation Life-Cycle

Guidance on Process validation began in 1987 to address consumer recalls and complaints and assure consumers that their products were consistently made with the utmost quality. This guidance underwent some significant fundamental changes in 2011. If processes were “validated” as prescribed by the FDA guidance then why were products being recalled? Why were customers complaining […]

Let’s Be Perfectly Clear

“The single biggest problem in communication is the illusion that it has taken place.” -George Bernard Shaw So, what is effective communication? And, how do I as an individual become an effective communicator? Effective communication is about the exchange of information so that everyone gets something valuable out of the exchange (whether it be a […]