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

  • 2020 (Not Final)
  • Location is not final

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

FDA`s GMP Expectations for Phase IV and First-in-Man Clinical Trials 2020 might be held in 2020 (Not Final).

More Details

Prices:
1699 US Dollar
Exhibition:
No exhibition
Organizer:
ComplianceOnline
Website:

Future Events

  • FDA`s GMP Expectations for Phase IV and First-in-Man Clinical Trials 2020 - 2020 (34511)

Past Events

  • FDA`s GMP Expectations for Phase III and First-in-Man Clinical Trials 2019 - 07-08 Nov 2019, Boston, MA, United States (34510)
  • FDA`s GMP Expectations for Phase II and First-in-Man Clinical Trials 2018 - 06-07 Dec 2018, Tampa Marriott Westshore, Tampa, FL, United States (34509)
  • FDA`s GMP Expectations for Phase I and First-in-Man Clinical Trials 2017 - 31 Aug - 01 Sep, 2017, Zurich, Switzerland (69883)
  • FDA`s GMP Expectations for Phase I and First-in-Man Clinical Trials 2017 - 10-11 Aug 2017, DoubleTree by Hilton Hotel San Francisco Airport, Burlingame, CA, United States (67248)
  • FDA`s GMP Expectations for Phase I and First-in-Man Clinical Trials 2016 - 18-19 Aug 2016, Philadelphia, PA, United States (31146)
  • FDA`s GMP Expectations for Phase I and First-in-Man Clinical Trials 2016 - 13-14 Jul 2016, Chicago, IL, United States (59976)

Important

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

Prices are for evaluation only.

Other Events with Similar Location or Organizer

Featured Conferences & Exhibitions