iSpeak Blog

The use of robotics to manufacture Advanced Therapy and Medicinal Products (ATMP) solves many challenges, including significantly limiting exposure to human generated contamination. There are steps to mitigate contamination points but with the strong endorsements recently made within the current revision to Annex 1 encouraging the use of robotics (Section 8.9),1

  • 1European...
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Taking place 8–10 May 2023 in Amsterdam, The Netherlands, the 2023 ISPE Europe Annual Conference will explore digital transformation and Pharma 4.0™, Annex 1, good engineering practice, supply chain resiliency and GAMP 5...
iSpeak Blog

As the biopharmaceutical industry grapples with faster commercialization of new drugs, along with an increased focused on sustainability, process simulation has never been more relevant. Whether for risk assessment or optimization, process simulation aims to represent a chemical or biochemical process by modeling the governing mechanisms that affect quality, yield, throughput, environmental...

19 April 2023 - 19 April 2023
Join ISPE Greater Los Angeles Area Chapter next week for our exciting event that will explore the ongoing digital transformation in BioPharma, hosted by Gilead. The event will begin with networking opportunities, followed by an introduction from Paul...
iSpeak Blog

The impact of paperless validation on the biotechnology industry is massive, and the overall effect is growing as adoption increases. Paperless validation is applicable to every type of validation in biotech: cleaning, process, equipment, facilities, utilities, and many others. Twenty percent of a project’s budget is devoted to validation activities, so streamlining profoundly impacts the...

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ISPE prides itself on providing our members the technical knowledge and networking resources necessary to make your mark on the industry and Shape the Future of Pharma™. Join today to take full advantage of the many...
Capgemini

CapgeminiEnabling your vision to produce and supply therapies and devices with unmatched levels of flow, efficiency and quality – sustainably and at scale

There is a symbiotic relationship among supply chain, manufacturing and quality in life sciences.

In this course, you will learn the various types of documentation and record-keeping practices used in the pharmaceutical industry, and how to establish and maintain clear policies and procedures to ensure compliance with regulatory requirements, and maintain product quality and patient safety...
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