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 […]
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 […]
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, […]
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 […]
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