Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
Featured Sessions
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Annex 1 Implementation & Pharma 4.0
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Pharma 4.0 Interconnected Facility Design and Construction
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General Session
The presentation will highlight the requirements for data management in the light of sterile manufacturing. The inspectors will share experiences with the implementation of Annex 1 in reference to Chapter 4 and Annex 11 based on new developments in the field. They will highlight expectations on successful contamination control strategy implementation and on data driven manufacturing processes and quality oversight.
All economic sectors, including the Life Science, are undergoing a significant transformation driven by the increasing focus on integrating environmental, social, and governance (ESG) criteria into their strategies and activities. This panel will explore the best strategies and practices by which manufacturing companies are responding to the pressures from different stakeholders (customers, regulators, suppliers, and employees), as well as regulators, implementing low environmental impact technical innovations and promoting a more sustainable workplace. Coming effective in 2025, the EU Legislation CSRD is paving the way for a huge change in business as it will require extensive and detailed disclosure about how sustainability issues are addressed by companies and related risks, opportunities and strategic action plans for the implementation of good business practices in their quality systems such as gender equity policies, sustainable procurement and supplier qualifications processes, as well as environmental impacts and decarbonization strategies.
• Reflect changes in regulatory and manufacturing environments and in the advanced technology in contamination control
• Incorporate principles of ICH Q9 Risk Management ICH Q10 Pharmaceutical Quality System and using this when taking advantage of the new possibilities by using innovative tools
• To correct inaccuracies and offer more detail to remove ambiguity
• Align this guideline with international requirements
• Clarify other areas of potential applicability of Annex 1 utilizing QRM principles
The new Annex 1 has been significantly expanded, however there is room for interpretation when it comes to how to be compliant with the updated version. In this presentation we will provide an 'auditors view' on how to verify/challenge if companies are compliant with the updated Annex one, illustrated by sharing experiences from recent audits.
The advancement in robotic telemanipulation permits individuals to perform manual interventions without entering sterile or hazardous areas. With stereo 3D vision, operators have a lifelike view of the environment, while telemanipulation software empowers precise control over robotic arms, akin to how surgeons operate with robotic surgery today.
Today Robot telemanipulation is being used by large Pharma companies to test use cases and plan operational rollout, minimizing human interaction with the sterile and hazardous areas.
The telemanipulation systems will also have additional benefits including the ability to record data and the 3D video enabling complete documentation of the interventions.
Hear From Top Industry Thought Leaders 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.