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Joseph Winslow
Jan 15, 20203 min read
Seven 2020 Resolutions to Use for Your Own
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...
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Joseph Winslow
Dec 16, 20195 min read
Leveraging Commissioning for cGMP Qualification/Validation
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...
1,269 views0 comments
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Joe Winslow
Nov 18, 20194 min read
Construction Project Delivery Methods – which is best for your project?
Design/Bid/Build (DBB) In the Design/Bid/Build (DBB) project method, the owner deals with an designers and builders in discreet steps of...
81 views0 comments
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Joe Winslow
Oct 13, 20193 min read
CE Marking and UL Listing…Aren’t they same thing?
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...
2,734 views0 comments
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Joe Winslow
Aug 19, 20194 min read
Value Engineering; not just for cheapskates
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,...
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Joe Winslow
Jul 13, 20192 min read
6 Reasons to Sub-Contract
Reducing cost is perhaps the most often cited reason for hiring sub-consultants to perform tasks that otherwise would be performed in...
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Joe Winslow
Jun 16, 20193 min read
Leadership Coaching - Go beyond being a good manager
Are you a technical expert in your field of engineering, IT, accounting, or science who now has management responsibilities? Are you...
51 views0 comments
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Joseph Winslow
May 15, 20194 min read
Writing an Effective Request for Proposal (RFP)
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...
45 views0 comments
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Joseph Winslow
Apr 15, 20193 min read
HEPA Filters 101
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...
929 views0 comments
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Joe Winslow
Mar 17, 20194 min read
Risk Assessment in the Biopharma and Medical Device Industries
Over the last several years, industry associations, and the FDA as well as other regulatory agencies have been putting more emphasis on...
34 views0 comments
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Joe Winslow
Feb 14, 20194 min read
Pharmaceutical Equipment Vendor Selection
In my experience over many years of specifying and purchasing biopharma manufacturing equipment, I have learned that many equipment...
80 views0 comments
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Joseph Winslow
Jan 13, 20194 min read
The 5 Elements of a Great Manager
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...
72 views0 comments
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Joe Winslow
Dec 14, 20183 min read
Funnies
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...
71 views0 comments
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Joe Winslow
Nov 12, 20183 min read
Understanding BioSafety Cabinets
There are 3 classes of Biosafety cabinets (BSC's), cleverly called class 1, class 2, and class 3, so you think understanding them would...
1,182 views0 comments
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Joe Winslow
Oct 15, 20185 min read
How to prepare for a cGMP Audit
In my career, I have probably participated in scores of GMP audits in various roles and from various perspectives. I have been the...
62 views0 comments
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Joe Winslow
Sep 16, 20183 min read
Equipment Decommissioning - Don't let this happen to you!
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...
58 views0 comments
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Joe Winslow
Aug 16, 20183 min read
8 Types of Water Recognized by the FDA
You probably already know that water in the biopharma industry is used as an excipient, for testing both raw materials and finished...
553 views0 comments
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Joseph Winslow
Jul 15, 20183 min read
Some thoughts on HVAC Qualification
While the world may not need one more article about HVAC system qualification, I am going to write this one anyway. There are many...
192 views0 comments
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Joseph Winslow
Jun 21, 20184 min read
Six things to consider when selecting a project manager
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...
41 views0 comments
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Joe Winslow
May 17, 20185 min read
Proposed Changes To EU Annex 1
Proposed Changes to EU Annex 1 – Manufacture of Sterile Medicinal Products The EU Annex 1 guidance for the manufacture of sterile...
51 views0 comments
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