Course Description:Control of materials is critical to ensure manufacturing consistency, resulting safety, quality and effectiveness of a product, and ultimately its continuous supply. FDA performs inspections to evaluate compliance with regulations applicable to material management systems. Material controls evaluated on inspections and applicable regulations will be discussed, followed by examples of recent inspectional observations from Forms FDA 483 issued to manufacturers of CBER-regulated products.
This recording features
a presentation by Ekaterina Allen, Ph.D., RAC.
Who should participate:
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Team members in CMC development projects
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
Access Duration:Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.