Heather Schwalje Archives - Emerson Automation Experts - Emerson Automation Experts

Posts Tagged ‘Heather Schwalje’

Electronic Batch Record Design Considerations

Posted in Life Sciences, Operations Management on Thursday, November 21st, 2013. 2 comments so far
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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 Good Manufacturing Practices (cGMP) compliance into Electronic Batch Record (eBR) initiatives. Her discussion centered around three areas: eBR […]

Managing Asset Performance and Collaborating in the Life Science Industry

Posted in Asset Optimization, Life Sciences, Reliability on Thursday, August 22nd, 2013. One comment so far
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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 Sea, assisting with an Asset Performance Management (APM) installation. His latest post from the […]

Good Manufacturing Practice Background and Overview

Posted in Life Sciences, Regulatory Compliance on Thursday, August 1st, 2013. No comments yet
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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 Life Science manufacturers in India and Bangladesh. Her presentation covered a good manufacturing practice (GMP) overview, GMP for computerized systems, […]

CPhI Pharma Evolution Guest Post-Electronic Batch Records: Are Your Systems Ready for Inspection?

Posted in Life Sciences, Operations Management, Regulatory Compliance on Thursday, May 23rd, 2013. 3 comments so far
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I wanted to share my guest post published at the CPhI Pharma Evolution website. There are some great comments, so join in if the post sparks some ideas. Stringent inspection-readiness policies are common with pharmaceutical and biotech manufacturers. From a computerized system standpoint, the rules of Part 11 (Electronic Records; Electronic Signatures – Scope and […]