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Quality Requirements For Biotech Products

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
  • Project Management Should Attend This biotech Products Masterclass
  • CMO Managers Should Attend This biotech Products Masterclass
  • Quality Assurance Personnel Should Attend This biotech Products Masterclass
  • Risk Management Should Attend This biotech Products Masterclass
  • Production Management Should Attend This biotech Products Masterclass
  • Maintenance Staff 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)
• Manufacturing process changes during clinical development

Key Takeaways Of Biotech Products In house Training

  • Understand
    • Regulatory landscape for national CTA procedures
    • How the assessors in Europe work
    • Voluntary Harmonized Procedure (VHP) in Europe
    • Quality challenges for Biotech-IMP development
    • Minimal required stability data for phase I to III
  • 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
  • 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
• Minimal required stability data for phase I to III
• 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

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


We also organize In-house training session on this topic, so if you are looking for In-house training in Biotech Products then click here. We Deliver In-house training for Biotech Products in all countries and all time zones

Start Time

9:00 am

December 5, 2019

Finish Time

5:00 pm

December 6, 2019

Address

Austria

Online Registration.

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:+44 2032 398083


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