A UL EduNeering course
US Food and Drug Administration-regulated products—food, drugs, biologics, and medical devices—must be created using good manufacturing practices (GMPs). This course reviews upcoming significant changes in FDA practices, including stepped-up emphases on inspections, warning letters, enforcement, and follow-up. Participants in this course learn about the challenges facing FDA and the industry from outsourced manufacturing and how companies can prepare for the coming changes.
- Current FDA regulatory environment
- Regulatory enforcement
- Supply chain and supplier monitoring challenges
- Risk prevention and future planning in the pharmaceutical, biological, and medical device industry
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields