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Life Sciences Blog
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Simplifying Recipe Creation in the Life Sciences Podcast
19 days ago
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Efficiently Managing Globally Dispersed Clinical Trial Documentation
Jim Cahill
I had a chance to connect with Emerson’s Michalle Adkins, a Senior Consultant on the Global Life Sciences Industry Solutions team. She shared a story about a leading company, which conducts clinical trials for pharmaceutical and biotech manufacturers...
21 Mar 2012
Mistake Proofing Pharmaceutical Production and Documentation Processes
Jim Cahill
As a follow up to the post, Using Operational Excellence Techniques to Understand and Solve Business Problems, Emerson’s Michalle Adkins shared a great story of one pharmaceutical manufacturer’s path to justify technology to help their business objective...
29 Feb 2012
Using Operational Excellence Techniques to Understand and Solve Business Problems
Jim Cahill
Pharmaceutical and biotech manufacturers, like other process manufacturers, are under constant pressure to improve the performance of their business—product quality, safety, plant efficiency, and throughput. Emerson’s Michalle Adkins, a senior consultant...
15 Feb 2012
Managing the Pharmaceutical and Biotech Technology Transfer Process
Jim Cahill
In a Research and Markets report, Technology Transfer Strategies – A Guide to Maximizing Returns Within the Pharmaceutical and Biopharmaceutical Industries, the authors note: The efficient and effective transfer of new technologies is widely recognized...
1 Feb 2012
Faster Product Releases with PAT Methods in Production Recipes
Jim Cahill
This week, the International Foundation Process Analytical Chemistry (IFPAC) is holding their 26th international forum and exhibition in Baltimore, Maryland USA. At this event, Emerson’s Chris Amstutz, Life Sciences industry consulting team director,...
26 Jan 2012
ASTM E2500-Early, Targeted Testing Leads to Faster Implementations
Jim Cahill
Last week, I highlighted Emerson’s Heather Schwalje thoughts on Continuous Process Verification per U.S. Food & Drug Administration (FDA) guidelines. In a comment, Pharmaceutical Manufacturing magazine senior editor, Paul Thomas, highlighted a great article...
25 Jan 2012
Continuous Process Verification per FDA Process Validation Guidance
Jim Cahill
It was just about a year ago that the U.S. Food and Drug Administration published their Guidance for Industry – Process Validation: General Principles and Practices. I caught up with Emerson’s Heather Schwalje, a senior consultant on the Life Sciences...
19 Jan 2012
Planning an Electronic Document Management Project
Jim Cahill
It’s great that Tim Alosi, from Emerson local business partner, New England Controls, was in town this past week. He saw the recent post, Shrinking Batch Record Creation Time and Document Management Complexity. Repligen is one of New England Controls...
28 Mar 2011
Shrinking Batch Record Creation Time and Document Management Complexity
Jim Cahill
I was digging around for the story behind the story of a biotech manufacturer, Repligen’s improved compliance through document management project. Emerson’s Lynn Richard was the solution architect who worked with the Repligen team. Given the production...
23 Mar 2011
Vertical Slices Improve Project Efficiency
Jim Cahill
In one of those fortuitous hallway conversations, I discovered that Emerson’s Bill Robertson had written a project management article for Pharmaceutical Manufacturing magazine. Bill is a certified project management professional (PMP) and professional...
3 Feb 2011
Organizational Change and Process Analytical Technology and Quality by Design
Jim Cahill
On Pharmaceutical Manufacturing magazine’s web site, PharmaManufacturing.com is an 8-minute video presentation given by Emerson’s Melissa Herkt. She gave the presentation, Excellence by Design: Melissa Herkt on The Case for PAT and QbD at the May 11-12...
8 Jun 2010
Bioreactor Electronic Workflow Project at WBF Conference
Jim Cahill
Emerson’s Christie Deitz and Bristol-Meyers Squibb’s Joe Maguire are presenting, Electronic Workflow for a Bioreactor, at the 2010 WBF North American Conference this week in Austin. Their abstract: Automating workflow and eliminating paper batch records...
26 May 2010
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