Discussion on Raw Material Methods and Specifications 2018

  • 04 Apr 2018
  • Webinar

Description

Discussion on Raw Material Methods and Specifications 2018 is a webinar that covers topics such as:

  • Justification for the use of a standard from the BP, EP, or JP in lieu of the USP/NF standard in the application
  • Acceptability of Standards from Alternative Compendia (BP/EP/JP)
  • Does compendia specification captures all of the tests necessary to ensure that the Active and inactive ingredient will perform as expected in the final drug formulation
  • Evaluate supplier specifications and methods listed on suppliers C.O.A (perform side by side and compare limits, supplier and user should interact to discuss Mutual agreement on quality requirements
  • Characterization of the composition of the excipient
  • The supplier`s commitment to conforming to appropriate excipient GMP requirements
  • Description of the API and excipient manufacturing process and facility
  • Regulatory information, (CFR, Mapp`s, Guidance`s, ICH, Orange book)

Discussion on Raw Material Methods and Specifications 2018 is intended for:

  • Product Development/Formulator / R & D Chemist
  • Quality Assurance/Control
  • Regulatory Affairs
  • Analytical Chemist/QC Lab

Past Events

Important

Please, check "Discussion on Raw Material Methods and Specifications" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Innovations, Quality assurance
Health & Medicine: Healthcare
Science: Chemistry
Technology: Materials

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