Biotech Products Training

Biotech Products Training   

Biotech Products  Masterclass  is going to happening  in Austria by Aurelius global  Masterclass.

This for Biotech Products In house- training in   Austria professionals that are new to the biotechnology industry, Production Management Should Attend This biotech Products Masterclass,  . The principles of regulatory-scientific Quality assessment for these  Biotech Products Training.

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
• Chemical Engineering 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)
• 
  
  • Learn
    • The principles of regulatory-scientific Quality assessment
    • EMA Guidelines and European Pharmacopeia Monographs
    • Manufacturing process development
    • Formulation development and choice of excipients
    • Batch record review and release methods
    • VISIT -HERE-https://aureliusglobalmasterclass.com/events/quality-requirements-for-biotech-products/