Aurelius Global Masterclass is providing
the best in house Biotech Products training and masterclass on latest
technologies in Austria, Europe.
- 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
• Release specifications versus InProcess Controls, ICH guidelines
• Analytical methods throughout clinical development, Batch data.- 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
- Training features
- Individual consultancy with the trainers
- Interactive lecturing
- All delegates receive comprehensive course documentation
- Certificate of Completion issued by Aurelius
- 5H+ of Networking with other industry experts
- Case studies from the trainer’s experience.
Registration Fee
€2496
Per Participant
- Start Time9:00 amDecember 5, 2019Finish Time5:00 pmDecember 6, 2019AddressAustria
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