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
• Validation Specialists Should Attend This biotech Products Masterclass.

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  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)
  • Manufacturing process changes during clinical development.
• ain
  • 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

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