ISPE India Pharma 4.0 Conference

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Challenges, Scope and Opportunities in 3D printing in drug product manufacturing. Dr Hemgir Gosavi Head Global Formulation Application Lab

In the talk we will have technical exchange about challenges, scope and opportunities in 3D printing in drug product manufacturing.

Adopting mature quality management practices supports a more reliable drug supply chain by reducing the occurrence of quality-related failures and improving the ability of establishments to maintain performance during expected and unexpected supply chain disruptions. Integrating business and manufacturing operations with quality practices and technological advancements can help achieve higher levels of maturity. This can optimize manufacturing process performance and product quality, enhance supply chain reliability, and foster proactive continual improvement.

This presentation will cover how human collaboration is important for automation

The presentation explains all the important points and also points out possible mistakes that can be made. The presentation is also supplemented by the global regulatory authorities training on the topic of robotics and their feedback the presenter did in 2023/2024

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

The presentation is based on the ISPE Pharma 4.0TM Operating Model and the ISPE APQ program, combining digital transformation and quality operations excellence, delivering compliance in pharmaceutical operations for free.

In the rapidly evolving pharmaceutical landscape of India, many organizations have embarked and had to navigate challenges on their journey to electronic batch records (eBMR). This presentation will delve into key lessons and results learnt from deploying eBMR across diverse industry processes, including Chemical API, OSD & Formulations, Medical Devices, and Cell & Gene Therapy. This session will use actual customer case-study’s to highlight how the projects were done, solutions to common challenges, and focusing on new Digitalisation capabilities that were made possible by replacing manual paper batch records across these different industry sectors.

During the lecture, the Special Interest Group Future Robotics will be presented as well as interesting applications that won in 2023

Sourav Ghosh Head of Business Development – Chemicals & Pharmaceutical Siemens Ltd.

This presentation will focus on how the Indian pharmaceutical industry can already leverage the power of Digital Twin technology to gain deep insights into their manufacturing process.  

This presentation will cover several aspects of IT Infrastructure control and Compliance. 

The pharmaceutical industry plays a vital role in public health, as it is responsible for developing and manufacturing life-saving medicines. In this critical sector, ensuring product quality and patient safety are paramount. To achieve these objectives, the industry is recognising the significance of cultivating a strong quality culture within organisations.

To meet the pharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive and vigilant approach that is science and risk-based, incorporating continuous improvement.

With rapid digitization, automation and the use of innovative technologies like AI/MLOps, we are also increasing the attack surface, and bringing in new cyber risks. The threat landscape is also going through substantial transformation and attackers are using the same innovative technologies to target and launch advanced and complex cyber-attacks. Most firms are at the cross roads due to unprecedented technological advancements and escalating cybersecurity challenges and hence organizations alike must gear up for the journey ahead.

In this session, we will discuss the state of cyber security, the shift in the threat landscape and the preparedness required to address the cyber security holistically. We will present a cyber security framework that addresses the components of governance, risk, compliance, technology solutions and cyber operations to address the cyber -challenge holistically. The learnings will come from risk-based spend, real-life cyber incident learnings and input, and vast experience in creating the cyber programs.

 AI for Quality Leaders: Legal landscape and key Principles for using AI in a GMP setting : Christopher Fanelli, Sidley Austin LLP