Archive for the ‘Life Sciences’ Category

Using Operational Excellence Techniques to Understand and Solve Business Problems

Posted in Life Sciences, Operations Management on Wednesday, February 15th, 2012. 3 comments so far
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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 on the Life Sciences industry team, shared details of an Operational Excellence (OE) program that she and her fellow consultants have developed. She notes [...]

Managing the Pharmaceutical and Biotech Technology Transfer Process

Posted in Life Sciences, Operations Management on Wednesday, February 1st, 2012. No comments yet
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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 as being a key component of gaining competitive advantage for corporations, industry and for individual nations. The rapidly changing commercial [...]

Faster Product Releases with PAT Methods in Production Recipes

Posted in Life Sciences, Operations Management on Thursday, January 26th, 2012. No comments yet
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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, gave a presentation, Incorporating PAT Methods into Production Recipes for Real Time Release. The U.S. Food and Drug Administration defines Process Analytical [...]

ASTM E2500-Early, Targeted Testing Leads to Faster Implementations

Posted in Life Sciences, Regulatory Compliance on Wednesday, January 25th, 2012. No comments yet
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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, A Practical Roadmap to Pharmaceutical Process Validation for Pharmaceutical and Biotech manufacturers. I saw another great analysis piece by Heather on [...]

Continuous Process Verification per FDA Process Validation Guidance

Posted in Life Sciences, Operations Management on Thursday, January 19th, 2012. 2 comments so far
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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 industry team. Heather shared key elements from this FDA process validation guidance document and how [...]

Planning an Electronic Document Management Project

Posted in Life Sciences, Operations Management on Monday, March 28th, 2011. No comments yet
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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 customers, and Tim had more to share on this story. The New England Controls team [...]

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Shrinking Batch Record Creation Time and Document Management Complexity

Posted in Bioprocess, Life Sciences, Operations Management on Wednesday, March 23rd, 2011. No comments yet
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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 volumes for this highly specialized family of proteins, the batch production process is composed of manual procedures and [...]

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Vertical Slices Improve Project Efficiency

Posted in Life Sciences, Project Services on Thursday, February 3rd, 2011. No comments yet
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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 engineer (PE). His article, Vertical Slicing for Customer Acceptance Tests, describes a different methodology for efficiently executing automation projects than has typically [...]

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Organizational Change and Process Analytical Technology and Quality by Design

Posted in Life Sciences, Operations Management on Tuesday, June 8th, 2010. No comments yet
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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 2010 FDA-Partnering with Industry conference. Melissa describes the process of organizational change as it applies to the Process [...]

Bioreactor Electronic Workflow Project at WBF Conference

Posted in Bioprocess, Data Management, Life Sciences on Wednesday, May 26th, 2010. No comments yet
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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 can provide many benefits, including reducing deviations, expediting batch review and release, improving real-time inventory management, and utilizing industry and [...]

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