FDA’s New Guidance on Emerging Technology Applications - Webinar CD/Transcript

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FDA’s New Guidance on Emerging Technology Applications: What it Really Means for Pharmaceutical Companies

With an eye toward improving product quality, the FDA is inviting drugmakers to join a program to evaluate emerging manufacturing technology. The program would allow for early engagement between the agency and participants to discuss manufacturing design and development issues. Further, it would give agency staff the opportunity to make suggestions on submission content related to emerging technology, according to draft guidance.

As part of the program, a CDER Emerging Technology Team (ETT) will serve as a point of contact for companies interested in implementing novel technology in the manufacture of a drug. The team will answer questions on what the FDA expects to see in submissions, facilitate regulatory review of a new technology, as well as resolve issues that can help inform how the FDA will assess submissions that involve a specific technology.

The emerging technology applications focused on pharmaceutical manufacturing will most likely be divided into four classes:

  • Existing technologies used in a novel approach to renovate an aging facility
  • Existing technologies that are new to the process used to bridge a severe compliance gap
  • Allowable technology changes during facility tech transfers
  • Real innovative technology applied to new products

But who is eligible and how does a company apply to become part of the program? Join on us for a comprehensive overview.

This presentation will discuss the most likely scenarios, including:

  • Aseptic filling suites /facilities 
  • All contained and disposable process equipment
  • Processing and handling of “combination products”
  • Renovation to remediate bioburden, cross contamination, and containment
  • Novel therapies /processes

This presentation will also explore the technologies expected to dominate the use of the new guidance:

  • Process
  • Facility
  • Therapies

And finally the presentation will discuss the operations of the ETT and its potential impact on drug shortages and the submission process.

At the end of this presenation you will know:

  • Key process technologies that ETT will oversee
  • Key facility technologies enabling the continuing march to smaller and cheaper classified spaces
  • Compliance decisions affected by the creation of the ETT
  • How the ETT is expected to conduct its operations
  • Compliance personnel
  • Regulatory affairs professionals
  • QA/QC personnel
  • Manufacturing executives
  • 510K application specialists
  • Strategic planner
  • Pharmaceutical scientists

Meet Your Presenters

Herman Bozenhardt has 39 years of experience in pharmaceutical, biotechnology and medical device manufacturing, engineering and compliance. Mr. Bozenhardt’s expertise is in a wide spectrum of processes, engineering, compliance and computer systems and related technologies. Mr. Bozenhardt is also a recognized expert in the area of aseptic filling facilities and systems, with service to Novo Nordisk, DSM, Catalent, Organon Teknika, Bausch and Lomb, Alcon, J&J, Bristol Myers Squibb, and Janssen Pharmaceuticals, as well as operations positions within Pfizer. Mr. Bozenhardt has extensive experience in the manufacturing of therapeutic biologicals and vaccines via cell culture technology, human plasma derivation and egg-based technologies. Prior to being an executive consultant, Mr. Bozenhardt was an engineering executive with Life Sciences International, Foster Wheeler, Aker Kvaerner, and KBR. Mr. Bozenhardt has a BS in Chemical Engineering and MS in System Engineering from the Polytechnic Institute of Brooklyn (now Polytechnic Institute of NYU).

Erich Bozenhardt is the head of the process group of the IPS Engineers in Raleigh NC. Mr. Bozenhardt has 10 years of experience in the biotechnology and aseptic processing business. Mr. Bozenhardt has led several biological manufacturing projects including cell therapies, mammalian cell culture, and novel delivery systems. Mr. Bozenhardt has a BS Chemical Engineering and a MBA, both from the University of Delaware.