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Regulatory Updates
Brett Marshall

Hear the latest update of regulatory landscape around the globe.

  • Brett Marshall (Head of Quality Assurance at Zuellig Pharma)

    Brett Marshall

    Head of Quality Assurance at Zuellig Pharma
Recent CNPPA Guidance and Technical Documents Related to Pharmaceutical Packaging
Yonghua Gao
  • Yonghua Gao (Deputy Secretary-General at China National Packaging)

    Yonghua Gao

    Deputy Secretary-General at China National Packaging
Applying the recent CDER – CBER COVID-19 Container Closure System Guidance: Glass Vials and Stoppers
Donald Klein
  • Donald Klein (CMC Consultant at DLK Consulting Services)

    Donald Klein

    CMC Consultant at DLK Consulting Services
Introduction of PDA Standards & Recent PDA Activities
Bettine Boltres
  • Bettine Boltres (Principal Scientific Affairs at West Pharmaceutical Services)

    Bettine Boltres

    Principal Scientific Affairs at West Pharmaceutical Services
Break
Automation in Secondary Packaging
Brett Marshall

Automation continues to bring benefits to all areas of the pharmaceutical industry. In this session, you will hear how full traceability, digitalization and new approaches to inspection & packaging can support adherence to regulatory requirements, timely delivery of product and ultimately more patient safety.

  • Brett Marshall (Head of Quality Assurance at Zuellig Pharma)

    Brett Marshall

    Head of Quality Assurance at Zuellig Pharma
Medical Device Tracking and UDI Serialization
Georg Schick
  • Georg Schick (Strategic Product Manager at Uhlmann Packaging Systems)

    Georg Schick

    Strategic Product Manager at Uhlmann Packaging Systems
New Requirements of the Inspection & Packaging Process for Small Batch Sized Medicines
Manuel Huber•Felix Riehn
  • Manuel Huber (Product Manager at Körber Pharma)

    Manuel Huber

    Product Manager at Körber Pharma
  • Felix Riehn (Head of Product Management at Körber Pharma)

    Felix Riehn

    Head of Product Management at Körber Pharma
Container Closure at Deep Cold Storage
Brett Marshall

One of the topics brought to the forefront by the COVID-19 pandemic is deep cold storage and transport, a topic that will remain critical moving forward especially in the area of cell and gene therapy. This session addresses the challenges primary packaging systems have to maintain good container closure integrity at these deep cold storage temperatures.

  • Brett Marshall (Head of Quality Assurance at Zuellig Pharma)

    Brett Marshall

    Head of Quality Assurance at Zuellig Pharma
Container Closure Systems for Cell & Gene Therapy
Roman Mathaes•Federico Sabini
  • Roman Mathaes (Head of Pharmaceutical Services at Lonza DPS)

    Roman Mathaes

    Head of Pharmaceutical Services at Lonza DPS
  • Federico Sabini (Lead Scientist, Primary Packaging at Lonza)

    Federico Sabini

    Lead Scientist, Primary Packaging at Lonza
Cold Storage Container Closure Integrity of Vial Primary Packaging Systems
Yusuf Oni
  • Yusuf Oni (Principal Engineer at Bristol-Myers Squibb Company)

    Yusuf Oni

    Principal Engineer at Bristol-Myers Squibb Company
Selection of a Primary Container Closure System Capable of Maintaining Closure Integrity During Deep Cold Storage
Sinue Gomez•Jennifer Riter
  • Sinue Gomez (Product Development Manager at Corning Pharmaceutical Technologies)

    Sinue Gomez

    Product Development Manager at Corning Pharmaceutical Technologies
  • Jennifer Riter (Senior Director, Analytical Services and Integrated Solutions of West Pharmaceutical Services)

    Jennifer Riter

    Senior Director, Analytical Services and Integrated Solutions of West Pharmaceutical Services
Break
Sustainability
Brett Marshall

Learn about the recent efforts of the industry to advance sustainable manufacturing and waste management.

  • Brett Marshall (Head of Quality Assurance at Zuellig Pharma)

    Brett Marshall

    Head of Quality Assurance at Zuellig Pharma
Sustainable Packaging in Merck Healthcare Supply Chain
Corinne Ondo Ngwa
  • Corinne Ondo Ngwa (Head of Sourcing Healthcare Innovation at Merck)

    Corinne Ondo Ngwa

    Head of Sourcing Healthcare Innovation at Merck
State of Biopharma Recycling – What Has Been Done and What Can be Done in Different Global Regions and What is on the Horizon
Jacqueline Hollands
  • Jacqueline Hollands (Global Manager, Product Recycling & Innovation at MilliporeSigma)

    Jacqueline Hollands

    Global Manager, Product Recycling & Innovation at MilliporeSigma
Container Closure Integrity (CCI) Testing Training
Oliver Stauffer

The Container Closure Integrity (CCI) Testing Training session will establish a foundation for CCI as it relates to parenteral applications. CCI is a vast field that has elevated in importance as the parenteral space continues to evolve. Effective strategies and solutions must be deployed to successfully navigate CCI requirements and provide the highest level of patient safety. This workshop will offer practical and logical tools to apply to individual cases. The objective of the workshop is to further enhance the participants ability to be CCI experts and will cover the following agenda.

- History of CCI and its purpose today
- What is CCI specifically for the parenteral space?
- Current state of regulatory environment
- Strategies and critical factors
- Technology landscape and selection
- Validation strategies
- Sustaining quality
- Bibliography and review of resources

  • Oliver Stauffer (CEO of PTI - Packaging Technologies & Inspection)

    Oliver Stauffer

    CEO of PTI - Packaging Technologies & Inspection