- Track 1: Biotech
Learn successful approaches and the variety of tools available to drive effective biotech facility
utilization in this uncertain environment.
- Track 2: Oral Solid Dosage Processing and Containment
You will hear from industry subject matter experts on matching containment to your process, top level
examples of a broad range of containment technologies that have been successfully demonstrated in the past,
and Case Studies relaying real life examples of contained Granulation and Compression equipment.
- Track 3: Process Validation
Apply the USFDA Process Validation Guidance using examples of implementation approaches for determining
process validation acceptance criteria, sampling plans, and number of batches for stage 2. You will also be
able to hear regulator reactions to these approaches, including strengths and shortcomings.