Author: Michalle Adkins At the March 21-23 Interphex 2017, Emerson exhibitor staff will be discussing three main themes: delivering capital projects on time with lower risk; comprehensive automation solutions for flexible, single-use facilities; and improving...
The integrity of the data behind the production of pharmaceutical products is paramount. In recent years, the U.S. Food & Drug Administration (FDA) has increasingly observed data integrity related Current Good Manufacturing Practices (CGMP) violations during CGMP...
The pharmaceutical and biopharmaceutical industries have been interpreting recent FDA draft guidance—Data Integrity and Compliance With CGMP Guidance—and exploring new areas such as continuous manufacturing. The Emerson Life Sciences team has a full program of forums,...
For pharmaceutical and biotech manufacturers, trends in the market place are driving changes in the way they have historically operated their production processes. I caught up with Emerson's Michalle Adkins who shared these trends with me. She identified six major...
Author: Michalle Adkins In April 2016, the FDA issued Data Integrity and Compliance With CGMP Guidance for Industry. This is on the heels of a lot of related 483s, warning letters, and more severe actions with respect to this issue. There are some interesting things...
A Pharmaceutical Manufacturing magazine study revealed that pharmaceutical and biotech manufacturers were challenged to achieve batch after batch repeatability. I came across a recently published whitepaper, Consistency and Repeatability Through Accurate Measurements....
Author: Michalle Adkins Before the holidays, I wrote a blog post, Life Experiences from a Woman in STEM, in the Emerson Exchange 365 Women in Stem group. I talked about growing up on a farm where I gained some early experiences with animals, vitamins, medications,...
Author: Michalle Adkins We are seeing a trend in the life sciences industry moving away from blockbusters to niche busters, population based medicines and even to the extreme of personalized medicines. The Emerson Life Sciences consulting team recently had the...
Pharmaceutical and biopharmaceutical manufacturers are challenged on many fronts, such as managing regulatory requirements, operating efficiency, and maintaining the right data required as part of the medicines and products produced. Emerson's Michalle Adkins was...
Pharmaceutical and biotech manufacturers face many economic and technical challenges including reduced prices and diminishing profits, rising research & development costs, increasing regulatory requirements and a greater need for optimized manufacturing...
Pharmaceutical and biotech manufacturers have stringent regulatory compliance requirements. These requirements must balance with the need for improvement and optimization to run safely, efficiently, profitably and in line with the business and quality objectives. In a...
From a recent Life Sciences symposium, we looked at issues in the advancement of process intelligence and analytics. Today we'll look at another work session from the symposium, Managing Data Through the Product Life Cycle. The general session was led by Amgen's...
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This blog features expert perspectives from Emerson's automation professionals on industry trends, technologies, and best practices. The information shared here is intended to inform and educate our global community of users and partners.