GMP Expectations for Products Used in Early Phase IND Studies 2018

  • 16 May 2018
  • Webinar

Description

GMP Expectations for Products Used in Early Phase IND Studies 2018 is a webinar that covers topics such as:

  • What to do at really early stages
  • Discussion of the elements found in the guidance document for Phase 1 material
  • What about preclinical studies?
  • What about special IND studies?
  • What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
  • Varying GMP activities that depend upon the nature of the IND product
  • What to do about QC activities such as instrument qualification, method validation, and process validation

GMP Expectations for Products Used in Early Phase IND Studies 2018 is intended for:

  • QA/QC Personnel who Need to Plan Work on Early Stage Material
  • Regulatory Affairs Personnel who Coordinate Activities for the CMC Sections of Submissions
  • Project Managers for Product Development Studies
  • R & D Personnel who Will Contribute data to CMC Sections
  • Consultants
  • Quality Systems Auditors

Past Events

Important

Please, check "GMP Expectations for Products Used in Early Phase IND Studies" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Medical laboratories, Pharma

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