Day 1 - Conference Agenda


Session 1 Current Regulatory Considerations
Session 2 Formulation Strategies and designs
Session 3 PAT Tools & QbD
Session 4 Morning Coffee and Networking Break
Session 5 Scale up and Tech Transfer
Session 6 Cycle Developments & Optimization
Session 7 Lunch Break
Session 8 Freeze drying of Proteins, Special Formulations
Session 9 New Technologies and Development
Session 10 Product Control - In Process, Visual Inspection, Container Closure Integrity
Session 11 Afternoon Coffee and Networking Break
Session 12 Manufacturing – Loading/Unloading of FD, Cleaning & Sterilization, Equipments
Session 13 Validation Maintenance – Self Temperature, Calibration of Probes, testing

Day 2 - Hands-on Training


Georg Frinke

Bayer Pharmaceuticals

Georg holds a degree in Engineering from UAS, Cologne, Germany. He is Process Engineer at Bayer Pharma and responsible for the technical operation of the parenteral facility. Previously, he worked as Process Engineer for Optima (Klee) and GEA Lyophil / Steris. Among others he is specialized in the development of customized Freeze-Drying processes (particularly upscaling with PAT) and in the qualification (FAT, SAT, IQ, OQ, PQ) of pharmaceutical freeze dryers.

Session 1 09:00 AM : Introduction & Overview of Freeze Drying Process
Session 2 10:00 AM : Nucleation: Sensors & PAT
Session 3 11:00 AM : Morning Coffee and Networking
Session 4 11:30 AM : Hands-on: Freezing of Sucrose in a Lyo
Session 5 01:00 PM : Lunch Break
Session 6 02:00 PM : Sublimation: Sensors & PAT
Session 7 04:00 PM : Afternoon Coffee Break
Session 8 04:30 PM : Desorption
Session 8 05:30 PM : Q-A Session

Day 3 - Hands-on Training


Georg Frinke

Bayer Pharmaceuticals

Georg holds a degree in Engineering from UAS, Cologne, Germany. He is Process Engineer at Bayer Pharma and responsible for the technical operation of the parenteral facility. Previously, he worked as Process Engineer for Optima (Klee) and GEA Lyophil / Steris. Among others he is specialized in the development of customized Freeze-Drying processes (particularly upscaling with PAT) and in the qualification (FAT, SAT, IQ, OQ, PQ) of pharmaceutical freeze dryers.

Session 1 09:00 AM : Repetition of Previous Day Theory & Transfer of a Freeze Drying Cycle
Session 2 09:30 AM : Hands-On: Recipe Development
Session 3 11:00 AM : Morning Coffee and Networking
Session 4 11:30 AM : Module Structure of a Freeze Dryer
Session 5 01:00 PM : Lunch Break
Session 6 02:00 PM : Module Structure of a Freeze Dryer (Cont.)
Session 7 03:30 PM : Afternoon Coffee Break
Session 8 04:00 PM : Evaluation of the Lyo experiment & samples of collapsed probe
Session 8 05:00 PM : Qualification Validation Hints for the SAT
Session 8 05:30 PM : Q-A Session

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