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