Biotech products Training

Biotech products Training

Aurelius Global Masterclass is providing the best in house Biotech Products training and masterclass on latest technologies in Austria, Europe.

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

• 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..
• • 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
  • Regulatory landscape for national CTA procedures
  • How the assessors in Europe work
  • Voluntary Harmonized Procedure (VHP) in Europe
  • Quality challenges for Biotech-IMP development.
• Training features
  • Individual consultancy with the trainers
  • Interactive lecturing
  • All delegates receive comprehensive course documentation
  • Certificate of Completion issued by Aurelius

• Registration Fee

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  €2496

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  Per Participant

• Start Time

  9:00 am

  December 5, 2019

  Finish Time

  5:00 pm

  December 6, 2019

  Address

  Austria
• https://aureliusglobalmasterclass.com/events/quality-requirements-for-biotech-products/