Biotech Products Training in Europe
Biotech Products Masterclass is going to happening in Austria by Aurelius global Masterclass.
Biotech Products Event Date 05 – 06 December 2019, Location – Austria
WHO SHOULD ATTEND THIS BIOTECH PRODUCTS MASTERCLASS IN AUSTRIA?
- Process Engineering Should Attend This biotech Products Masterclass
- Formulators Should Attend This biotech Products Masterclass
- Technology Transfer Should Attend This biotech Products Masterclass
- Manufacturing Management Should Attend This biotech Products Masterclass
- Validation Specialists Should Attend This biotech Products Masterclass.
KEY TOPICS OF BIOTECH PRODUCTS TRAINING IN EUROPE
• Regulatory framework for Clinical trials of Biotech-IMPs
• The quality challenges for BiotechIMPs GMP requirements for IMPs
• Manufacturing of the Drug Substance and IMP
• Requirements for processvalidation
• IMPs comparators and placebos.- Gain
- Stepwise requirements for process validation
- Characterization of physicochemical quality attributes
- Control of Drug Substance and IMPs
- Best practice: Presentation of the comparability data for the IMPD
- Quality related aspects of GMP inspections for IMPs
Registration Fee
€2496
Per Participant
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