Virtual delivery available!
UPCOMING PROGRAM DATES: This training is scheduled according to demand
Program Logistics
- Program Start: This training is scheduled according to demand
- Registration Deadline: Two weeks prior to program start
- Time: 8:00am – 4:00pm
- Location: Biomanufacturing Education & Training Center (BETC) WPI Gateway Park 2, 50 Prescott Street (2nd floor), Worcester MA
- Cost: $2,925
- CEU: 2.3
- There are no academic prerequisites for this program
PREREQUISITE
A 2-hour online lecture must be viewed anytime prior to the start of the program.WHAT YOU WILL LEARN
This course will take the students through the journey of using a combination of classroom presentations and case studies such that they will be “ready” to participate in Q-b-D related activities related to a Biotech product.
- Introduction to Q-b-D principles- A science- and risk-based approach
- Product understanding – Critical Quality Attributes (CQAs) – patient safety and needs
- Process understanding
- Development of Process and Analytical Control Strategy
- Statistical Methods and data analysis
- Quality Risk Management (QRM)
- Design of Experiments (DOE)
- Process Optimization & Response Surface Methodology– Ranges, Design Space,
- Root causes analysis – FMEA, risk ranking and apply FMEA to Control Strategy selection
- Technology Transfer to manufacturing and Continuous Process Verification Strategy
- CASE Studies
CUSTOMIZED TRAINING PROGRAMS
Looking to schedule a private course for your employees or colleagues? Our team of subject matter experts will work with your company to develop training specific to the needs of your organization. Contact us to learn more about customized biomanufacturing training programs:Catherine Bouthillier
Senior Manager, Healthcare Corporate Partnerships
cbouthillier@wpi.edu
(508) 831-4653