Emerson Exchange 365

Activity

Prototype Manufacturing Operations Management Projects

Jim Cahill

The post Prototype Manufacturing Operations Management Projects appeared first on the Emerson Process Experts blog. The ANSI/ISA-95 standard defines models for the information flows between the instrumentation and automation layers up to the enterprise information layers for process manufacturers and producers. Moving up the levels increases the need for people, processes and workflows. Click to enlarge . At the…
- 19 Feb 2015
Continued Process Verification in the Process Validation Lifecycle

Jim Cahill

The post Continued Process Verification in the Process Validation Lifecycle appeared first on the Emerson Process Experts blog. In 2011, the U.S. Food and Drug Administration (FDA) issued a Guidance for Industry – Process Validation: General Principles and Practices . It highlighted a third validation stage goal of continued process verification (CPV) for: …continual assurance that the process remains in a state…
- 22 Jan 2015
Enabling Release by Exception Manufacturing

Jim Cahill

Michalle Adkins Manager, Life Sciences Consulting The Emerson Exchange conference October 6-10 in Orlando, Florida USA is rapidly approaching. I caught up with Emerson’s Michalle Adkins who mentioned that her team of Life Sciences consultants would be...
- 11 Sep 2014
Improving Technology Transfer by Earlier Adoption of Standards and Software Platforms

Jim Cahill

In 2011, the U.S. Food & Drug Administration (FDA) published their Guidance for Industry – Process Validation: General Principles and Practices . A PharmManufacturing.com article, A Framework for Technology Transfer to Satisfy the Requirements of the...
- 21 Aug 2014
Implementing Process Analytical Technology and Continuous Process Verification

Jim Cahill

Gary Mitchell Senior Industry Consultant – Life Sciences In the 4:42 video, Life Science Drug Process Development and Manufacturing , Emerson’s Gary Mitchell highlights the changes occurring for pharmaceutical and biotech manufacturers. Gary opens...
- 12 Aug 2014
What Do You Do for a Living?

Jim Cahill

Michalle Adkins Manager, Life Sciences Consulting Author: Michalle Adkins I often get asked, “So, what do you do for a living?” Boy is that a loaded question. When I say that I manage a group of Life Sciences Industry Consultants for E... Read the full text.
- 4 Aug 2014
What to Do When the DeltaV Calc Block Is Not Enough

Jim Cahill

Author: Jonathan Lustri The process control domain continues to get more and more sophisticated as Emerson’s customers use process models and increasingly sophisticated calculations to optimize process control. Once case in point is an example I saw at...
- 24 Jul 2014
Integrated Data Management throughout Drug Development Phases

Jim Cahill

This week, the Bio International Convention (Bio 2014) is happening in San Diego, California. Several of Emerson’s Life Sciences consultants, including Zuwei Jin, are there to discuss some of the issues and trends in pharmaceutical and biotech manufacturing...
- 26 Jun 2014
Joining the Life Sciences Consultants and Friends at 2014 Bio International

Jim Cahill

Author: Gary Mitchell The Emerson Life Sciences Industry Solutions Group consultants, including Saroj Patnaik, Michalle Adkins, Jonathan Lustri, Zuwei Jin and me, will be joining Hillary Clinton, Sir Richard Branson and over 15,000 other attendees from...
- 12 Jun 2014
Optimizing Formulation, Fill and Finish Manufacturing Facilities

Jim Cahill

Pharmaceutical and biotech manufacturing processes are complex and require well integrated and documented flows of information from upfront forecast demand and customer orders through the production process to inventory receipt and order fulfillment....
- 22 May 2014
Wireless Applications in Life Sciences

Jim Cahill

By Gary Mitchell More and more process manufacturers, including Life Sciences, if not already embracing it, are considering the use of wireless technology in their facilities. Wireless technology can range from wireless networks enabling mobile operators...
- 24 Apr 2014
Implementing Quality by Design

Jim Cahill

Many manufacturers in the Life Sciences industry are challenged to respond to a new paradigm for process development and manufacturing. The FDA’s cGMP for the 21st Century initiative is driving the industry to change its development and manufacturing...
- 20 Feb 2014
America Needs Apprentices

Jim Cahill

For mature markets with retiring “baby boomers“, how do we best facilitate the knowledge transfer to the next generation of instrumentation and automation professionals? Emerson’s Gary Mitchell, a Senior Life Sciences Industry Consultant, shares some...
- 6 Feb 2014
Planning Process for Life Science Optimization Projects

Jim Cahill

For many process manufacturers with lean engineering staffs, partnering with outside automation specialists is critical for successful automation and optimization projects. Emerson’s Michalle Adkins, who leads the Life Sciences Industry Solutions consulting...
- 17 Jan 2014
Continuous Manufacturing for Solid Dose Form Pharmaceuticals

Jim Cahill

Emerson’s Jonathan Lustri explores the trend towards continuous manufacturing for sold dose pharmaceuticals and the technologies and practices that make this possible. This past year I have become aware of a very big change that is coming to the pharmaceutical...
- 19 Dec 2013
Bridging Islands of Automation

Jim Cahill

While integration technologies have helped bridge “islands of automation” over the years, some process manufacturers still have parts of their automated processes disconnected from the rest. Emerson’s Gary Mitchell, a senior industry consultant on the...
- 5 Dec 2013
Electronic Batch Record Design Considerations

Jim Cahill

Last week, the 2nd International Summit on GMP, GCP & Quality Control was held in Chicago, Illinois USA. Emerson’s Heather Schwalje, a senior Life Sciences consultant, presented Moving beyond part 11; Quality assurance considerations for translating Current...
- 21 Nov 2013
Prototyping Key in Manufacturing Execution System Projects

Jim Cahill

In an earlier post, Five Strategies for Mitigating Automation Project Risk, we highlighted the importance of prototyping: Risks in budget, schedule, changes, and project execution can be reduced with a prototyping strategy. Prototyping helps incorporate...
- 7 Nov 2013
Fluidized Bed and Bin Blender PAT Applications

Jim Cahill

In the early 2000s, a Wall Street Journal article, New Prescription For Drug Makers: Update the Plants, shared the news: The FDA [U.S. Food and Drug Administration] has concluded that the industry needs to adopt manufacturing innovations, partly to raise...
- 24 Oct 2013
Establishing a Process Analytical Technology Program

Jim Cahill

We’re now just a couple of weeks away from the September 30-October 4 Emerson Exchange conference in the Dallas/Fort Worth area of Texas. Today’s the last day to save $200 on the conference fee, so register today if you’re planning on joining us. If you...
- 16 Sep 2013
Managing Asset Performance and Collaborating in the Life Science Industry

Jim Cahill

In two very different industries, I have some updates to share from Emerson consultants. On the reliability front, when we last checked in with Emerson’s Richard Barnes, a Senior Asset Optimization Consultant, he was at a refinery located on the Black...
- 22 Aug 2013
Good Manufacturing Practice Background and Overview

Jim Cahill

Highly regulated industries, such as pharmaceutical and biotech manufacturing, face a myriad of compliance issues, which vary by region of the world and continuously involve. Emerson’s Heather Schwalje presented Regulatory Drivers- GMPs 21st Century to...
- 1 Aug 2013
Aligning Stakeholders in Operations Management Projects

Jim Cahill

The ISA-95 (IEC 62264) Enterprise-Control System Integration (part 1, part 2, part 3, part 4, part 5) international standard provides a model to help define the boundaries between the enterprise systems and process control systems. As manufacturing operations...
- 18 Jul 2013
Interfaces to Consider for Manufacturing Execution System (MES) Projects

Jim Cahill

Projects to connect your process operations to your business processes and workflows typically require connections with several specialized software platforms. For manufacturers in the pharmaceutical and biotech industries, these electronic connections...
- 9 Jul 2013
How to Install Batch Analytics on Earlier DeltaV Software Versions

Jim Cahill

As we get closer to the Emerson Exchange conference September 30-October 4 in Grapevine (Dallas-Fort Worth, Texas area), I wanted to highlight some of the presentations which have been accepted by the board members. Emerson’s David Rehbein, a Senior Industry...
- 20 Jun 2013