FDA`s GMP Expectations for Phase IV and First-in-Man Clinical Trials 2020

  • 2020

Description

FDA`s GMP Expectations for Phase IV and First-in-Man Clinical Trials 2020 is a conference that covers topics such as:

  • GMP Requirements for a Phase 1 Study
  • Overview of GMP requirements
  • QC Function procedures and requirements
  • Personnel documentation and requirements
  • Control of components, containers and closures – methods and specs
  • Facility and Equipment requirements
  • Vendor selection & management
  • Manufacturing & Records during phase 1 studies with an eye toward later development
  • Specific requirements for various types of products: biologics, combinations, sterile products
  • Process Validation to conduct for phase 1 clinical supply process
  • Preparing relevant SOPs for early stage development
  • Multi-product facilities considerations
  • Providing relevant information in the IND application

FDA`s GMP Expectations for Phase IV and First-in-Man Clinical Trials 2020 brings together:

  • Manager
  • Directors
  • Lead workers in Regulatory Affairs Quality Assurance and Quality Control
  • Supervisors
  • Workers who will review GMP documents for early phase products
  • Workers who will prepare GMP documents for early phase products

Past Events

Important

Please, check "FDA`s GMP Expectations for Phase IV and -in-Man Clinical Trials" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device, Medical laboratories, Pharma
Science: Life Sciences & Biology

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