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Upcoming Events

2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference & Executive Forum

September 21, 2020 - September 23, 2020

Webinar: Digital Transformation Strategy Development in Biologics Manufacturing: One Site’s Journey with BioPharma Asia

October 1, 2020

A walkthrough of the journey towards Digital Transformation for Takeda’s Massachusetts Biologics Operations Site. This presentation shares the journey towards enhancing the site’s digital and analytics capabilities and bringing it closer to a digital world and the progress and processes taken thus far.

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2020 ISPE Europe Biotechnology Virtual Conference

October 5, 2020 - October 7, 2020

Webinar: CPV + AI: The Formula To Succeed In Biopharma Manufacturing

October 13, 2020

Process validation encompasses a lifecycle approach which includes three stages: Process Design or Development (Stage 1), Process Performance Qualification (Stage 2) and Continued/On-going Process Verification (CPV, Stage 3). The 3 stages are typically a long manufacturing journey where extensive data is accumulated, trended, and analyzed. Thus, CPV highly recommends process automation, PAT (Process Analytical Technologies) and a deep knowledge of the manufacturing process and drug product. Continued process verification enables concepts like real time release (RTR), use of continuous manufacturing or Golden Batch, but it is still not adopted in Pharma.

The established conditions (EC), critical quality attributes (CQA), and critical process parameters (CPP) are not enough to describe a real, complete picture and history of the process. Manual operations, environmental variables, seasonality components and many other factors are affecting the process inducing a permanent variability. Statistics and Multivariable Analysis can be complemented with artificial intelligence (AI) to boost the stage 3 towards a reality and a continuous state of the art in biopharma manufacturing.

During the webinar, panelists will explain how Artificial Intelligence allows predicting, classifying, recognizing and recommending improvements to the process which leads to enhanced product quality and process performance (2 sides of the same coin) in CPV.

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ISPE Annual Meeting and Expo

November 2, 2020 - November 6, 2020

2020 ISPE Europe Pharma 4.0™ Virtual Conference

November 17, 2020 - November 18, 2020

IoT and Smart Pharma
San Diego, California, USA

March 16, 2021 - March 17, 2021

Come see us in San Diego!

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