Workshop Accelerated Stability Assessment Programme (ASAP)

 

 

Location: RAMADA Hotel Bad Soden D-65812, Germany

Date: Wednesday 25th February 2015

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

See programme for details. Price: €320 (includes lunch). Please reserve your place by emailing: patricia@amebisltd.com