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Viral Safety for Biologic

Viral Safety for Biologic Event Date 05- 06 December 2019, Location – Austria

WHO SHOULD ATTEND VIRAL SAFETY MASTERCLASS IN AUSTRIA?

  • Process Engineering Should Attend This Viral Safety Masterclass
  • Formulators Should Attend This Viral Safety Masterclass
  • Technology Transfer Should Attend This Viral Safety Masterclass
  • Manufacturing Management Should Attend This Viral Safety Masterclass
  • Validation Specialists Should Attend This Viral Safety Masterclass
  • Chemical Engineering Should Attend This Viral Safety Masterclass
  • Project Management Should Attend This Viral Safety Masterclass
  • CMO Managers Should Attend This Viral Safety Masterclass
  • Quality Assurance Personnel Should Attend This Viral Safety Masterclass
  • Risk Management Should Attend This Viral Safety Masterclass
  • Production Management Should Attend This Viral Safety Masterclass
  • Maintenance Staff Should Attend This Viral Safety Masterclass

KEY TOPICS OF VIRAL SAFETY TRAINING IN EUROPE

  • Sources and types of virus contamination
  • Virus safety regulatory background
  • Techniques for virus inactivation and removal in the Downstream Process
  • Viral clearance studies for clinical trials material in EU and US
  • Virus clearance studies for market authorization
  • Evaluation and characterization of viral clearance procedures
  • Limitations of virus validation studies
  • Select the correct model viruses for the clearance studies

KEY TAKEAWAYS VIRAL SAFETY TRAINING IN EUROPE

  • Get insights of important regulatory guideline and requirements for market applications
  • Background of tests for the characterization of cell lines
  • Inactivate & remove viruses during downstream processes
  • Conduct a viral clearance study from study plan, interaction with CRO to final validation report
  • Select the correct down scale model for the different clearance steps
  • Prepare the validation studies into required regulatory documents

 

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 Viral Safety for Biologic then click here. We Deliver In-house training for Viral Safety for Biologic 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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