Success in HPAPI Manufacturing

Thursday, April 21, 2011
USA: 11:00 a.m. EDT • 10:00 a.m. CDT • 8:00 a.m. PDT
Europe: 17:00 MEZ

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Overview: Highly Potent API (HPAPI) manufacturing poses various challenges to different organizations. Whether you are part of a pharmaceutical company or a supply organization, special consideration must be paid to the design of the working areas and process development before a process can be transferred into HPAPI manufacturing. In this webinar, Conrad Roten will provide an overview of the key factors to run a successful HPAPI process in the plant. Included in the presentation are several short case studies highlighting the application of some of these key factors in the preparation phase, including the application of process analytical technology (PAT) to develop safe processes, as well as information on the preparation of a successful HPAPI manufacturing process.

Areas covered in the webinar:
  • Key factors for successful HPAPI manufacturing
  • PAT application in the development of HPAPI processes
  • Verification programs in HPAPI manufacturing
  • Case Studies in PAT application for HPAPI projects as well as verification studies and the necessary preparation for HPAPI manufacturing

Who should attend?
  • Chemists from R&D and Production
  • Procurement and outsourcing professionals
  • Chemical engineers involved in developing safe and efficient production facilities
  • Regulators interested in gaining a better understanding of the procedures required for robust HPAPI development and manufacture

Main Speaker:
Dr. Conrad RotenDr. Conrad Roten
Group Leader, Early Phase & HPAPI R&D
Lonza Custom Manufacturing
Lonza AG, Switzerland




Accompanied by:
Dr. Tobias MerzDr. Tobias Merz
Lead, PAT Team
Lonza Custom Manufacturing
Lonza AG, Switzerland





Dr. Rainer JossenDr. Rainer Jossen
Head, Launch Plant Operations
HPAPI
Lonza Custom Manufacturing
Lonza AG, Switzerland




Moderator:
Ann M. ThayerAnn M. Thayer, Ph.D.
Senior Correspondent
C&EN



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