Pharmaceutical and Biotech Automation Knowledge Exchange

Emerson's Michalle Adkins

The pharmaceutical and biopharmaceutical industries have been interpreting recent FDA draft guidance—Data Integrity and Compliance With CGMP Guidance—and exploring new areas such as continuous manufacturing.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, workshops and short courses available for manufacturers in the Life Sciences industries at to October 24-28 Emerson Exchange conference in Austin.

Emerson’s Michalle Adkins shared some of these highlights with me. A cornerstone is the Life Sciences Industry Forum. This forum is titled Life Sciences / Pharmaceuticals – Complete, Consistent, Accurate Breadcrumbs: Data Integrity Unveiled. Here is its abstract:

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. Data Integrity is defined as complete, consistent and accurate data that is attributable, legible, contemporaneously recorded, original or true copy, and accurate. Data Integrity includes all aspects of instrumentation, field devices, automation, IT, and procedural solutions. While the Guidance document provides several recommendations, the implementation of these can vary based on the interpretation of “appropriate controls”, “critical data”, “data vs record”. The Life Sciences Industry can use risk-based strategies based on process understanding, knowledge management technologies, and business models to meet core regulatory requirements. As continuous manufacturing strategies are progressing, due to shear increase in data and importance of real-time data, the theme of data integrity becomes even more relevant for the industry. In this session, we will discuss the data integrity topic and its importance for continuous manufacturing.

Speakers include Doug Hausner at the Engineering Research Center for Structured Organic Particulate Systems at Rutgers University and Chris Wubbolt with QAVC Consulting. Daniel Reid with Shire, Midhu Varghese with AbbVie, and Michalle have been coordinating and will be facilitating the forum. Additionally, the Emerson management team will give an overview of our Life Sciences initiatives and close the forum.

Beyond this Industry Forum, some other Life Sciences-related workshops that may be of interest include:

In the exhibits area you’ll find hands on demos including Batch Analytics in real time and connect with many of the Life Sciences consultants. Walking tours through the exhibit hall will include stops showing continuous process verification, batch control, virtualization, operations management, asset reliability, control valves, pressure regulators, solenoid valve manifolds, flow meters with smart meter verification, pH, dissolved oxygen and conductivity analyzers and pressure, temperature & level measurement instrumentation designed for pharmaceutical and biotech manufacturing.

If you haven’t yet registered to join us, do so today. You can also connect and interact with other pharmaceutical and biotech experts in the Life Sciences group in the Emerson Exchange 365 community.

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