INTERPHEX 2019 Keynote Series: Contamination in Aseptic Manufacturing

April 3, 2019

In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.

Ongoing product recalls, warning letters, and questions about the revisions to the European Union’s GMP Annex 1, present challenges and opportunities in aseptic drug manufacturing. In a keynote session at INTERPHEX 2019, experts will review and debate the issues, and present potential solutions.

Wednesday, April 3: 1:30–3 pm
Minimizing Contamination in Aseptic Manufacturing
Experts look at new technologies, approaches, and services that are preventing contamination, recalls, and regulatory noncompliance in a crucial area of drug manufacturing.
Moderator: Agnes Shanley, senior editor, Pharmaceutical Technology

1:30–2 pm
Aseptic Processing: Industry Trends and Challenges
Jim Agalloco, principal, Agalloco Associates 

2:15–2:40 pm
Tech Talk: Top Issues and How New Technologies and Services Address Them
Learn about current industry challenges related to aseptic processing and possible solutions including new technology advances, supply chain integration, and enhanced roles for CDMOs.
Panelists:
Chris Procyshyn, CEO, VanRx
Jo Anne Jacobs, fellow and manufacturing technology specialist, Catalent 
Nicholas Zasada, director of process development and manufacturing, Vetter Development Services USA, Inc. 
Paul Lopolito, technical service senior manager, Steris Corporation, Life Science Formulated Chemistries
Arnab Ganguly, scientist and technology manager, IMA Life North America, Inc. 
Moderator: Jim Agalloco, principal, Agalloco Associates 

2:40–3:15 pm 
Regulatory Issues and Innovation 
Experts will debate key issues related to aseptic processing and regulatory oversight including the following: 

  • Ending the Catch 22 of aseptic technology innovation: How can regulators encourage the use of innovative technologies when they haven’t yet been mentioned in a new drug application or other filing? 

  • Annex I: Does it signal deeper misunderstandings of basic concepts and science on the part of regulators, and what can be done about it? 

Panelists:
Jim Agalloco, principal, Agalloco Associates
Chris Procyshyn, CEO, VanRx
Jo Anne Jacobs, fellow and manufacturing technology specialist, Catalent 
Nicholas Zasada, director of process development and manufacturing, Vetter Development Services USA, Inc. 

 

Click here to see more Keynote series information.

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