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ISPE Boston – International Aseptic Conference

March 2 - March 3

The 2020 ISPE Aseptic Conference will focus on providing flexible and reliable solutions for the implementation and management of the latest in aseptic, barrier, containment, and aseptic best practice technologies, including Automated Visual Inspections. Now in its 29th year, this year’s program will feature regulatory and industry experts from FDA, SKAN, F. Hoffman La Roche, Bosch, Fresenius Kabi, Evonik, Merck, and many others to provide your company with the practical tools to improve your manufacturing capability and reliability. Case Studies representing innovative large and small-scale facility and process design will offer insights into successful projects designed to meet unique customer and patient needs.

Now in its 29th year, this signature event has established itself as the pharmaceutical industry’s leading source on advancing aseptic and barrier operations and providing invaluable opportunities for peer-to-peer learning through interactions with industry and regulatory leaders—making the presence of the Boston Area Chapter important.

Over the course of two days, you will:

  • Explore the hottest topics in aseptic manufacturing, like robotics, ATMPs, and cell therapy scale-out planning
  • Join industry-critical conversations during an interactive panel discussion on automated visual inspections and the event favorite—the interactive regulatory panel
  • Make valuable connections at the largest aseptic networking event with 400+ professionals during multiple networking opportunities, such as small group breakout hot-topic discussions
  • Plus, maximize your experience with in-depth training covering four essential areas of pharmaceutical manufacturing on 4–5 March

Featured speakers include:

  • Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER
  • Robert Sausville, Director, Div. Case Management, FDA/CBER
  • David Doleski, Compliance Head for Biologics Quality Operations, Sanofi
  • Christophe Riedel, CEO, Claranor SA
  • Eugen Goidenko, Executive Vice President, Bausch Advanced Technologies Inc.
  • Dawn Watson, Director, Microbial Control & Sterile Site Support Sterile & Validation COE, Merck & Co., Inc.
  • And more!

Who Should Attend?

  • Sterile Products Processing Community of Practice
  • Engineering system owners or project managers responsible for aseptic processing equipment
  • Validation personnel responsible for aseptic processing equipment qualification
  • Quality Assurance personnel responsible for maintaining the integrity of aseptic systems
  • Quality Assurance personnel responsible for cleaning and prevention of cross contamination
  • Equipment manufacturers and suppliers providing state-of-the-art aseptic technology including robotics
  • Aseptic manufacturing professionals and management
  • Aseptic processing consultants and regulatory specialists
  • Manufacturers of design, facilities, building, commissioning, validation
  • Quality Systems/Assurance and Quality Control (QA/QC) including microbiology professionals
  • Compounding pharmacy and small-scale facilities professionals
  • Industrial Hygienist for operational safety in aseptic processing
  • Professionals new to Aseptic processing and product protection
  • Plant managers

Details

Start:
March 2
End:
March 3
Website:
https://www.ispeboston.org/events/?eventID=1060

Venue

Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852 United States
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