It is that time of year when many of us make resolutions to improve our lives. If you don’t want to revisit the time-tested decrees of...

In the last 10 years or so, there has been more movement in the Biopharma industry to use risk-based qualification and one outcome of...

Design/Bid/Build (DBB) In the Design/Bid/Build (DBB) project method, the owner deals with an designers and builders in discreet steps of...

The short answer is “No, they are not the same thing” Many of OSHA’s safety standards for Construction and General Industry (e.g., 29 CFR...

Value Engineering or VE as it is sometimes called is often a fancy way of saying “Our projected project cost is higher than our budget,...

Reducing cost is perhaps the most often cited reason for hiring sub-consultants to perform tasks that otherwise would be performed in...

​ ​Are you a technical expert in your field of engineering, IT, accounting, or science who now has management responsibilities? Are you...

In my career, I have been on both sides of the RFP process. I have written them as the owner, and as a consultant in the owners rep...

If you’ve worked in the biopharma or medical device industry for very long, you have at least seen or heard of HEPA filters. HEPA is an...

Over the last several years, industry associations, and the FDA as well as other regulatory agencies have been putting more emphasis on...

In my experience over many years of specifying and purchasing biopharma manufacturing equipment, I have learned that many equipment...

We all know of or have worked for managers who succeed in getting the work done, and directing the people who work for them. Yet...

As we near year's end, I thought I would take a break from the serious technical subjects and try to make my readers smile. Here a three...

There are 3 classes of Biosafety cabinets (BSC's), cleverly called class 1, class 2, and class 3, so you think understanding them would...

In my career, I have probably participated in scores of GMP audits in various roles and from various perspectives. I have been the...

If you’ve been in this business long enough, you’ve most likely run across the need to decommission cGMP equipment or facilities. On the...

You probably already know that water in the biopharma industry is used as an excipient, for testing both raw materials and finished...

While the world may not need one more article about HVAC system qualification, I am going to write this one anyway. There are many...

One of the first things that needs to be considered when a new project is initiated is who the project manager (PM) will be. There are a...

Proposed Changes to EU Annex 1 – Manufacture of Sterile Medicinal Products The EU Annex 1 guidance for the manufacture of sterile...