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Workshops, Town Halls & Panel Discussions, Oh My!

Anne Kantardjieff, PhD
Niranjan S. Kulkarni, PhD

2018 ISPE Annual Meeting & Expo Banner

Track Highlights 2018 ISPE Annual Meeting & Expo

The 2018 ISPE Annual Meeting & Expo is fast approaching! This conference has always been a great networking platform for the Biopharmaceutical Industry, however this year the educational agenda will steal the spotlight. This year’s educational agenda is very rich with content and presentations by elite pharma subject matter experts. The six tracks include:

  • End-To-End Supply Chain Management
  • Facilities and Equipment
  • Information Systems
  • Innovation Forum
  • Product Development & Production Systems (PDPS)
  • Quality Systems and Regulatory

These tracks offer workshops, town hall meetings, panel discussions, insights into trending topics, and advancements in their respective domains.

End-to-End Supply Chain Management

The End-to-End Supply Chain Management track will cover topics ranging from traditional, yet challenging, supply chain problems including capacity planning, modeling and simulations of supply chains, and designing robust, resilient, reliable facilities, and supply chains. This track will also cover supply chain related technology and trending topics, such as, CAR-T supply chain challenges and solutions, serialization, and Industry 4.0, to name a few.

Facilities and Equipment

The Facilities and Equipment track will include exciting presentations and a workshop. This track discusses topics that can help:

  • Renovate an existing biotech plant
  • Implement an Oncology facility in China
  • Apply and qualify a PAT System
  • Understand the right maintenance strategy.

Presentations on the state of the sterile products industry, along with, updates on the revision of the Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition are also featured in this track.

Information Systems

The Information Systems track features interesting applications of using data and IT features to improve the biotech industry. Topics include:

  • Applications for Quality and Predictive Control
  • Digital Plant
  • Next Generation Manufacturing Controls
  • Digital Transformation in the Clinical World
  • Pharma 4.0 Paradigm

Trending topics, such as, blockchain, cybersecurity and data integrity, cloud computing and forensic auditing for data integrity will also be presented.

Innovation Forum

This year, the Innovation Forum will feature two sessions focused on cell and gene therapy; one showcasing the novel bioprocessing approaches needed to bring these therapies to market and a second focused on the manufacturing and facility design challenges created by these emerging biotherapeutic classes. This track will also highlight innovative digital tools that are enabling continuous and next generation manufacturing and PAT technologies that can support these manufacturing paradigms.

Product Development & Production Systems

The Product Development & Production Systems track covers a spectrum of relevant and trending topics including:

  • Use of descriptive statistics and data sciences
  • Technology transfer acceleration techniques
  • Pharma 4.0
  • Approaches to product/process development for continuous manufacturing,
  • Automation trends

This is just the tip of the iceberg of content that will be covered in the Product Development & Production Systems track.

Quality Systems & Regulatory

When it comes to quality and regulatory affairs, all eyes turn to the Quality Systems & Regulatory track. This track will include presentations from pharma industry and regulatory agencies subject matter experts. Discussions include:

  • Regulatory affairs before and after a natural disaster
  • Drug-device combination products
  • Lifecycle process validation
  • Regulatory considerations for new manufacturing technologies
  • And many more!

The expertise, experience and passion the presenters bring to the educational agenda for the 2018 ISPE Annual Meeting & Expo are destined to be a true learning and interactive experience for everyone who attends.

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