
Stand Out in Your Field with Specialized Training
This advanced, hands-on training opportunity will implement the global body of knowledge of ISPE to advance the understanding of drug substance and drug product manufacturing, utilizing the commercial scale operational aspects of the Biomanufacturing Training and Education Center (BTEC - located on North Carolina State Centennial Campus in Raleigh, NC) through a series of immersive and hands-on exercises that address current, real world manufacturing challenges.
Overview of BTEC Facility
Raleigh, NC
“Manufacturing in a state of control.” Sounds simple. However, the reality facing companies that produce products via the ever-changing platforms in biomanufacturing where product protection, safety, and efficacy are the foundation principles. Production operations must adhere to the “business model” of the manufacturing enterprise while not running afoul of the vast global network of regulatory agencies, often not in complete harmonization as ICH would lead us to believe.
This advanced, hands-on training opportunity will implement the global body of knowledge of ISPE to advance the understanding of drug substance and drug product manufacturing, utilizing the commercial scale operational aspects of the Biomanufacturing Training and Education Center (BTEC - located on North Carolina State Campus in Raleigh, NC) through a series of immersive and hands-on exercises that address current, real world manufacturing challenges. The operational resources of BTEC will provide support as the thought leadership of ISPE’s extensive biomanufacturing curriculum and their Baseline and Good Practice Guides provide a roadmap to understanding and achieving the “state of control” that represents success.
Objectives:
Using the commercial-scale operations of the BTEC Facility as an instructional aide, Attendees will participate in real-world exercises that focus on controlled manufacturing scenarios. These exercises will enlist the collaboration of BTEC Staff to simulate scenarios requiring critical thinking and analysis of information in a Team environment.
These Team exercises will be supplemented with additional course scenarios that will provide thought leadership solutions to real-world challenges based on actual Industry case study information.
Day 1
Day 2
Training course times are listed in Eastern Standard Time (EST). Find your personal viewing time on the World Clock.
0800 – 1000 | Content/Exercises |
1000 - 1015 | Morning Break |
1015 - 1200 | Content/Exercises |
1200 - 1300 | Lunch |
1300 - 1430 | Content/Exercises |
1430 - 1445 | Afternoon Break |
1445 - 1700 | Content/Exercises |
0800 – 1000 | Content/Exercises |
1000 - 1015 | Morning Break |
1015 - 1200 | Content/Exercises |
1200 - 1300 | Lunch |
1300 - 1430 | Content/Exercises |
1430 - 1445 | Afternoon Break |
1445 - 1700 | Content/Exercises |
Early Registration *Ends 13 Sept 2025 | Regular Registration | |
---|---|---|
Member | $2,700.00 | $3,000.00 |
Non Member | $3,000.00 | $3,300.00 |
Government | $1,200.00 | $1,200.00 |
Student | $750.00 | $750.00 |
Affiliate | $2,000.00 | $2,000.00 |