FDA`s GMP Expectations for Phase III and First-in-Man Clinical Trials 2019

  • 15-16 August 2019
  • San Francisco, CA, United States

FDA`s GMP Expectations for Phase III and First-in-Man Clinical Trials 2019 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 III and First-in-Man Clinical Trials 2019 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

FDA`s GMP Expectations for Phase III and First-in-Man Clinical Trials 2019 will be held in San Francisco, CA, United States on 15-16 August 2019.

Venue

San Francisco,
California,
United States
  View all Hotels near Venue
Booking.com
1699 US Dollar
No exhibition
ComplianceOnline
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Past and Future Events

  • FDA`s GMP Expectations for Phase IV and First-in-Man Clinical Trials 2020 - 2020 (34511)
  • FDA`s GMP Expectations for Phase III and First-in-Man Clinical Trials 2019 - 15-16 Aug 2019, San Francisco, United States (34510)
  • FDA`s GMP Expectations for Phase II and First-in-Man Clinical Trials 2018 - 6-7 Dec 2018, Tampa, United States (34509)
  • FDA`s GMP Expectations for Phase I and First-in-Man Clinical Trials 2017 - 31 Aug - 1 Sep, 2017, Zurich, Switzerland (69883)
  • FDA`s GMP Expectations for Phase I and First-in-Man Clinical Trials 2017 - 10-11 Aug 2017, Burlingame, United States (67248)
  • FDA`s GMP Expectations for Phase I and First-in-Man Clinical Trials 2016 - 18-19 Aug 2016, Philadelphia, United States (31146)
  • FDA`s GMP Expectations for Phase I and First-in-Man Clinical Trials 2016 - 13-14 Jul 2016, Chicago, United States (59976)

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.