Program Overview:
This training course examines current solid dosage technology and provides case studies for troubleshooting and investigational events for process deviations, discusses QMS and GMP inspection preparation, and provides process improvements and recommendations. Using a Process and Production scenario based tools including Mixing, Blending, Drying, Sizing, Tableting, Encapsulating and Coating provides attendees with a visual demonstration of current manufacturing and validation practices.
Program Modules:
Module 1
- Understand the solid dosage formation
- Pharmaceutical regulatory requirements
- Raw material Dispensing/Formulation; Blending
- Direct Compression
- Wet Granulation
- Dry Granulation
Module 2
- Drying; Compression/Encapsulation
- Coating; Packaging and Receiving/Warehousing Operations.
- Manufacturing equipment and the technology advancements for drug optimization
- An overview of product characteristics and how they dictate the unit operations method
Module 3
- Effective process monitoring techniques during the scale-up and technology transfer processes
- A summary of the principles of QbD in OSD manufacturing processes
Module 4
- GMPs influence unit operations and subsequent equipment design, production suite design, control and monitoring requirements.
- An analysis of PAT, PPP, MES, CMP, and PLC.
