ISPE India Pharma 4.0 Conference

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Christian Wölbeling, Körber Pharma Software; Founder & Chair of the ISPE CoP „Pharma 4.0“

The ISPE Baseline® Guide: Pharma 4.0 provides the structural capabilities framework needed for realizing successful and lasting transformations 

Digitization and Use of AI in Pharmaceutical Manufacturing and Quality. The opportunities and Regulatory challenges. Mark Birse, Vice President Technical, Strategic Compliance Consulting 

This talk emphasizes the importance of applying the "Human 4.0" criteria, which refers to the initiative's human element. 

This presentation will explain key terms and highlight some cutting edge AI technologies that have major benefits in both productivity and quality compliance in Pharmaceutical Manufacturing.

This presentation will focus on Technologies to Scale your Pharma 4.0 Journey: Manish Shah , Managing Director Sarla Advantech

This talk emphasizes the importance of applying the "Human 4.0" criteria, which refers to the initiative's human element. 

The core of this presentation will address the points and concepts for the realizatdion of robot-based loading and unloading systems will also be shown on the basis of case studies. These case studies will deal with the loading and unloading of existing freeze dryers as well as with the construction of new systems.

The presentation explains the use of Risk Management Concepts for Scripted and Unscripted Testing 

Enhancing Efficiency and Compliance in Pharmaceutical Manufacturing using AMR : Vimal Manchanda, Chief Operating Officer at Samvardhana Motherson Health Solution Limited.

This presentation delves into the groundbreaking integration of Automated Mobile Robots (AMRs) within the Laminar Air Flow (LAF) area of pharmaceutical vial filling, illustrating how this implementation streamlines operations, enhances efficiency, and ensures compliance in critical pharmaceutical manufacturing processes.

This talk emphasizes the importance of applying the "Human 4.0" criteria, which refers to the initiative's human element. 

 This presentation will go through a methodology that uses publicly available information and produces a site risk analysis, including what the risk factors are, how to determine them, how to categorize them as critical, major, or minor, how weigh them to produce a composite score, and how to evaluate the signals over time.