Joseph Winslow
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, 2019
- 5 min
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...
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Joe Winslow
- Nov 18, 2019
- 4 min
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...
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Joe Winslow
- Oct 13, 2019
- 3 min
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...
1,119 views0 comments
Joe Winslow
- Aug 19, 2019
- 4 min
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, 2019
- 2 min
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, 2019
- 3 min
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...
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Joseph Winslow
- May 15, 2019
- 4 min
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...
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Joseph Winslow
- Apr 15, 2019
- 3 min
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...
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Joe Winslow
- Mar 17, 2019
- 4 min
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...
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Joe Winslow
- Feb 14, 2019
- 4 min
Pharmaceutical Equipment Vendor Selection
In my experience over many years of specifying and purchasing biopharma manufacturing equipment, I have learned that many equipment...
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Joseph Winslow
- Jan 13, 2019
- 4 min
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...
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Joe Winslow
- Dec 14, 2018
- 3 min
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...
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Joe Winslow
- Nov 12, 2018
- 3 min
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...
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Joe Winslow
- Oct 15, 2018
- 5 min
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...
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Joe Winslow
- Sep 16, 2018
- 3 min
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...
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Joe Winslow
- Aug 16, 2018
- 3 min
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...
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Joseph Winslow
- Jul 15, 2018
- 3 min
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...
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Joseph Winslow
- Jun 21, 2018
- 4 min
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...
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Joe Winslow
- May 17, 2018
- 5 min
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...
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