Amebis ASAP Workshop

WORKSHOP

ACCELERATED STABILITY ASSESSMENT PROGRAMME (ASAP), Crowne Plaza Hotel, Blanchardstown, Dublin

Thursday 20th March 2014 9:30am — 4:30pm

Led by: Ken Waterman, President, FreeThink Technologies, Inc., USA

ASAP or Accelerated Stability Assessment Programme allows users to predict drug product and substance shelf–life quickly and accurately, typically in two to four weeks. Experiments are carried out in a designed range of temperature and relative humidity conditions. Stability analyses using ASAPprime® provide robust, science-based criteria for selecting packaging, formulation, ingredient supplier and manufacturing process without the need for repeated and lengthy laboratory studies. ASAP has now been adopted by a wide range of pharmaceutical and consumer product companies.

Agenda

  • The science behind ASAP: isoconversion, humidity sensitivity, statistics
  • Using ASAP to optimise package selection
  • Formulation design in an ASAP environment
  • Bringing ASAP into companies: learnings from companies that adopt ASAP
  • ASAP and the regulatory world: IND, NDA, ANDA, post-approval, excursions
  • Case studies
  • Experimental design and practice
  • Understanding the application of ASAP to QbD
  • Future additions to ASAP

Price: €300 (includes lunch).

Limited spaces - Please reserve you place by emailing: imelda@amebisltd.com

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