FDAnews Announces — FDA’s New Guidance on Emerging Technology Applications: What it Really Means for Pharmaceutical Companies Webinar, March 10, 2016

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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.

FDA’s New Guidance on Emerging Technology Applications:
What it Really Means for Pharmaceutical Companies
March 10, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/emergingtechapp

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agency staff the opportunity to make suggestions on submission content related to emerging technology, according to draft guidance.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?
This webinar 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 webinar will also explore the technologies expected to dominate the use of the new guidance:

  • Process
  • Facility
  • Therapies

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

At the end of this webinar attendees 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

Meet the 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.

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.

Who Will Benefit:

  • Compliance personnel
  • Regulatory affairs professionals
  • QA/QC personnel
  • Manufacturing executives
  • 510K application specialists
  • Strategic planner
  • Pharmaceutical scientists

Webinar Details:
FDA’s New Guidance on Emerging Technology Applications:
What it Really Means for Pharmaceutical Companies
March 10, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/emergingtechapp

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/emergingtechapp
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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