Date: To be confirmed
Instructor: Dr. Mel Dong
Location: To be confirmed
Contact us for more information: bbc@bluebell-consulting.com
Focused on the process validation for medical devices, this two-day course will introduce the necessary knowledge and practical skills in conducting process validation projects.
FDA QS regulations, FDA and GHTF guidances on process validations are referenced and situation analyses/case studies are adopted to discuss the industry and common practices when validation is conducted in multiple different companies. Participants will also learn how to use a risk-based approach to develop process validation programs.