Agenda

Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.

Featured Sessions

 

Unpacking Recent ICH Guidelines
Oct 15, 2024 | 1530 - 1700
Presenters: Multiple
Join us at the Global Implementation Strategies Forum to engage with industry experts and regulators on the Global Adoption Status and Implementation Strategies for ICH Q2(R2)/Q14 and Q12 guidelines. Discover how these science- and risk-based approaches to lifecycle management are ensuring the continued quality of drug substances and drug products worldwide. Explore how ICH Q12 provides tools for effective post-approval change management and regulatory reporting, while ICH Q2(R2)/Q14 focuses on the development, validation, and lifecycle of analytical procedures. 
ISPE Regulatory
Town Hall
Oct 16, 2024 | 0950 - 1120
Presenters: Multiple
Join us at the Regulatory Town Hall where you can engage with International Regulators and Industry thought leaders on topics including progress on Mutual Reliance, new methodologies on information sharing between industry and regulators, new product development paradigms, the use of mechanistic models to support physiologically based pharmacokinetics useful in product development and evaluations of medicines and vaccines. 

All session times are listed in Eastern Time (ET). Find your personal viewing time on the World Clock.

Speakers

Selected filters:

  • Mathew Kishe
Mon, 14 Oct
1045 – 1115

Advanced Analytics for Alarm Prioritization and Management

Manufacturing - Quality Control - Operational Excellence
Mathew Kishe, Eli Lilly
Wifred Mascarenhas, Eli Lilly
In today's pharmaceutical manufacturing landscape, the effective management of alarms is paramount for ensuring operational efficiency, product quality, and regulatory compliance. Eli Lilly, a global leader in pharmaceuticals, has embarked on a journey to enhance its alarm management practices using innovative technologies. Leveraging an advanced analytics platform, Eli Lilly has initiated a transformative initiative aimed at consolidating alarms and optimizing their management workflows. By implementing a centralized approach, Eli Lilly aims to achieve consistency in alarm handling, improve response times, and reduce the potential for alarm fatigue among operators. Furthermore, this initiative serves as a catalyst for global collaboration by facilitating data and knowledge sharing between sites. Through the standardization of workflows and the establishment of a centralized repository for alarm data, Eli Lilly is fostering a culture of continuous improvement and harmonization across its manufacturing network.
Mathew Kishe
Principal Engineer - Automation
Eli Lilly
Wifred Mascarenhas
Executive Director - Data & Analytics
Eli Lilly

Hear From Top Industry Thought Leaders and Regulators on the Challenges and Solutions Impacting the Pharmaceutical Industry

Speaker Qualifications

Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.

Agenda Changes

Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.