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.

Biotechnology is a challenging area that combines science and Biotech Products   Training  . who pursue this Biotech Products Training in 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.

• 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
  • The site master file (SMF).
• 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

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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/