ICQ Blog — Biopharma’s CQV Experts

Happy Holidays

Marie Kondo’ing Your Project and Getting Organized!

There is a current, popular trend called the “Konmari” Method created by Marie Kondo, which basically teaches you how to organize your possessions and life around you. This method, when put into practice, is designed to organize a person while keeping what is important and valuable and eliminating that of what is not. Overall, the message behind the method is about one key word – “Organization”.

ISPE NJ Holiday Party

Join ICQ Consultant’s Michael Gatta, Michael Johnson, Steven Torre and Jason Torre tonight at the ISPE NJ Holiday Party.

The Back Office

If you’ve ever been bugged by a back-office coworker needing timely, verifiable, detailed information, you may wonder why that is.

PDA NE Dinner Meeting – Visit Us!

ICQ Consultants, Michael Gatta and Peter Broomes will be attending tonight’s PDA New England Dinner Meeting & Berkshire Facility Tour.  Please make sure to stop and say hello to them if you are there!  The link below will provide the events agenda and description. PDA NE – NE Dinner Meeting

Different Ways to Fasten Biological Indicators (BI)

Introduction to BIs Biological indicators (BIs), as defined by ANSI/AAMI and ISO, are test systems containing viable microorganisms providing a defined resistance to a specific sterilization process. A biological indicator provides information on whether necessary conditions were met to kill a specified number of microorganisms for a given sterilization process, providing a level of confidence in […]

Project Schedules: How to Help Yourself and the Project Scheduler

Lack of experience with project scheduling by project team members is one of the biggest frustrations that a project manager/project scheduler faces.  Projects in a matrix organization are often staffed with team members who are not familiar with project schedules.  The team members provide input on tasks that they will need to perform to complete […]

Mods and Pods in BioPharm

Flexible Manufacturing: Mods and Pods in BioPharm Early facility design and BioPharm beginnings Ever since I was a child, I have loved to build.  Like many kids of my generation, I grew up playing with Legos, Tinker Toys and Erector Sets.  These objects would fill my days, providing hours of entertainment.  The best part about […]

Temperature Controlled Systems: Refrigerators and Freezers

Have you ever completed the temperature mapping / qualification testing for a walk-in refrigerator or freezer and felt good about the data? That is until someone asked you to relate what the numbers mean in relation to the system and what was happening inside the unit. You knew the results met the acceptance criteria, but […]

Industry 4.0 and the Manufacturing Facilities of Tomorrow

On May 16, I attended the ISPE event Pharma 4.0: The Next Industrial Revolution in Manufacturing for Automation, Controls, and Decision Making. Technology is advancing at an ever-increasing pace, and it can be difficult to keep up with the newest innovations. One of the major advances in recent years is called the Internet of Things, or IoT. IoT […]

Hiring: Raleigh – Durham Area, CQV Professionals

ICQ is currently hiring for multiple openings in the Greater Raleigh Area.  If you or anyone you know may be interested, please apply here or email a copy of your resume to resumes@icqconsultants.com.  

Validation 101: System Requirements

Why are requirements and specifications needed in validation? Validation is testing a system to standards or acceptable criteria. If your own requirements are not in place, then you will end up validating a system to someone else’s standards. There are thousands of features and conditions to consider and considering them beforehand allows your company to […]