Presentations from the workshop may be downloaded by using the links below.
Monday, September 24, 2018
- The Development of the Guidelines, Early Work of LAL & Regulations – Dr. James Cooper
- Understanding LAL Testing Methods – Jill Schultz
- LAL-Related Interference – John Dubczak
- Software Overview – Meg Provenzano
Tuesday, September 25, 2018
- Demonstrating Endotoxin Process Control – Matt Paquette
- Introduction to Rapid Endotoxin Detection: Testing with Today’s Advanced Technology – Matt Paquette
- Laboratory Investigations and Out of Specifications (OOS) – Clare Lenich
- LAL – Related Calculations and Validation with Calculation Exercises – Jill Schultz
- Manufacturing Variability & Critical Control Points – John Dubczak
- Progress and Pitfalls of the Monocyte Activation Test as Related to Product Quality Assessment – Dr. Jessica Campbell
- Optional: IQ/OQ/PQ – Ben Fisher
Wednesday, September 26, 2018
- Analyzing Common Causes and Citations of FDA 483s Related to QC Microbiology – Jason O’Hare
- Data Integrity Strategies for the QC Micro Lab – Matt Paquette
- Environmental Monitoring and Contamination Control Plan with Case Studies – Jessica Rayser
- Operational Impact of Prominent Microbial Identification Strategies – Dr. Prasanna Khot
- Species and Strain-Level Identification for Members of Closely-Related Groups: Sequencing with Protein-Coding Targets and MLST – Erin Patton
- The Importance of Having Relevant and Accurate Library Entries – Dr. Prasanna Khot
- Why Trend Data? Case Studies & Solutions – Vanessa Figueroa
Thursday, September 27, 2018
- Amplified ATP Bioluminescence Rapid Sterility Test Validation Utilizing a Defined Method for Stressing Microorganisms – Shawn Sweeney
- An Analysis of the Arising Abandonment of Rapid Methods Following Approval – Dr. Ron Smith
- Points to Consider when Validating a Rapid Micro Method – Brice Chasey
- Rapid Microbiological Methods in Pharmaceutical Manufacturing: Perspectives from the FDA – Dr. Julie Nemecek
- The Modern Microbiome – Vanessa Figueroa