2020 ISPE Annual Meeting & Expo

Nov 2, 2020 ‐ Nov 6, 2020



Sessions

Opening Plenary SessionOpening Plenary Session

Preview Available

Opening Plenary Session

Nov 2, 2020 9:00am ‐ Nov 2, 2020 11:00am

Identification: NA20CENOV1/KEYNOTEMON

Speaker(s):

Exhibitor ShowcaseExhibitor Showcase

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Exhibitor Showcase

Nov 2, 2020 10:00am ‐ Nov 6, 2020 5:00pm

Access to our Exhibitor Showcase

Speaker(s):

Advancing ATMPs in the City of Brotherly Love

Nov 2, 2020 1:00pm ‐ Nov 2, 2020 2:30pm

Identification: NA20CENOV1/SES201

Advancing ATMPs in the City of Brotherly Love | As interest in the Advanced Therapy Medicinal Product (ATMP) and cell and gene therapy market continues to grow at a rapid pace, novel processes are demanding facility and technology infrastructures unlike any that have previously existed. ATMPs could transform health for many patients, and all of us involved in the field, including those of us specializing in facility design, have a role to play in helping this new era of medicine to reach its potential. Please join us for a panel discussion centered around industry trends and challenges facing the ATMP industry and how Philadelphia is working together to achieve our end goal - to get products to patients.

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Pharma 4.0 Concepts & Cases Pharma 4.0 Concepts & Cases

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Pharma 4.0 Concepts & Cases

Nov 2, 2020 1:00pm ‐ Nov 2, 2020 2:30pm

Identification: NA20CENOV1/SES202

Pharma 4.0 Concepts & Cases | The ISPE Pharma 4.0TM Operating Model was developed as a practical model for implementing a holistic approach for the digitalization of a pharmaceutical organization end-to-end. – While we are not there yet, some interesting case studies are available, showing the concepts are working and providing expected benefits. This session will overview how we can adjust our Pharmaceutical Quality Management System to embrace technology and increase data integrity, use our massive data stores for action by leveraging data analytics for Container System optimization and capping, and how facility management and building system support can increase productivity and reduce costs for pharmaceutical firms. For example, one core component of the Pharma 4.0TM Operating Model is the digitalization of the ICH Q10 Pharmaceutical Quality System (PQS), which is enabled by a Data Integrity by Design approach and a clear definition of Process Maps and Data Flows. Having this in place, data analytics will help to improve quality, performance and robustness of the processes and help to prevent drug shortages for the benefit of the patient.

Speaker(s):

Innovation Ecosystems Innovation Ecosystems

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Innovation Ecosystems

Nov 2, 2020 1:00pm ‐ Nov 2, 2020 2:30pm

Identification: NA20CENOV1/SES203

Innovation Ecosystems | In a world of accelerating change, companies can no longer rely of top down strategies to adapt and innovate. Rather, the ability to harness the wisdom of the crowd is becoming central to drive incremental and disruptive innovations across discovery, development, manufacturing, and supply. Yet the best practices to harness the talents of the masses remain under-developed. This session will present different viewpoints on how to inspire and challenge, crowdsource and connect ideas, sponsor, and fund projects through progressive stages, and ultimately drive results from the innovators that permeate throughout modern corporations. As a result of the session, participants can expect to take away best practices for setting up their own innovation ecosystem, or better engaging and enhancing the ecosystem in which they already find themselves.

Speaker(s):

Process Technology Process Technology

Preview Available

Process Technology

Nov 2, 2020 1:00pm ‐ Nov 2, 2020 2:30pm

Identification: NA20CENOV1/SES204

Process Technology | This session will focus on technologies associated with the future state of manufacturing. Critical to successful process scale-up is defining process capability and robustness including integration of data analytics, in silico modeling, and process control. The presentations in this session cover a wide variety of technologies from spray dried dispersion, to small-scale bioreactors to the use of single use technologies. The benefits of using these tools to evaluate the technologies and how this leads to successful scale-up and implementation will be presented.

Speaker(s):

The Importance of Quality Management Maturity

Nov 2, 2020 1:00pm ‐ Nov 2, 2020 2:30pm

Identification: NA20CENOV1/SES205

The Importance of Quality Management Maturity | FDA introduced interest in quality management system maturity and a rating system of maturity of manufacturing facilities in their 2019 Drug Shortages report. Experienced industry, FDA and academic speakers will present on 1) The background, status and content of ISPE’s industry-for-industry quality maturity framework. This framework has been developed over the past 3 years and evolved from ISPE’s research in response to FDA Quality Metrics draft guidances, and its work to issue the Cultural Excellence report. This program is scheduled to deliver its first module in assessment and potential improvement of CAPA maturity; 2) FDA’s journey to assessing quality management maturity; 3) An academic perspective on how to assess quality maturity

Speaker(s):

Improving Vaccine Delivery to the Developing World

Nov 2, 2020 1:00pm ‐ Nov 2, 2020 2:30pm

Identification: NA20CENOV1/SES206

Improving Vaccine Delivery to the Developing World | Current delivery of liquid injectable vaccines to the developing world is currently based on the multi-dose vial. Investigations have shown that the cost per delivered dose with multi-dose vials is significantly higher than the initial cost per dose at the factory; wastage through loss of unused doses, glass breakage product loss and temperature excursions all add to the final cost per dose. Blow/Fill/Seal (BFS) advanced aseptic technology has been investigated for the application of single dose vaccine packaging. Ongoing work has shown that the technology is viable for producing single dose primary packaging for Live Attenuated and inactive vaccines. The work includes container and device designs for oral and injectable vaccines, product stability studies, cost comparison between packing technologies, and developing world human factor studies to test the container design and function. This presentation will introduce participants to BFS technology and its application to cold chain products, single dose container designs for oral and injectable vaccines, and the challenges around filling adjuvants.

Speaker(s):

FOYA Category Winner Presentations

Nov 3, 2020 10:30am ‐ Nov 3, 2020 12:00pm

Identification: NA20CENOV1/SES100A

FOYA Category Winner Presentations | Get an in-depth look at the latest, state-of-the-art developments being implemented by ISPE’s 2020 Facility of the Year Awards (FOYA) Category Winners. Hear from the project teams themselves as they share the technical story of their project and learn how excellence was delivered via innovative thinking.

Speaker(s):

FOYA Category Winner Presentations

Nov 3, 2020 12:30pm ‐ Nov 3, 2020 2:00pm

Identification: NA20CENOV1/SES100B

FOYA Category Winner Presentations | Get an in-depth look at the latest, state-of-the-art developments being implemented by ISPE’s 2020 Facility of the Year Awards (FOYA) Category Winners. Hear from the project teams themselves as they share the technical story of their project and learn how excellence was delivered via innovative thinking.

Speaker(s):
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