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Stability & Shelf Life of Biologics

Product Stability Conditions

Product Stability Event Date 24th to 25th May, Location: Munich, Germany

MASTERCLASS OVERVIEW OF STABILITY ZONES

A course covering stability & shelf-life regulatory landscape and identifying proper analytical methods for stability assessment.

WHO SHOULD ATTEND PRODUCT STABILITY TRAINING?

  • Product Stability Managers and Specialists should attend this training
  • Regulatory Managers and Specialists should attend this training
  • QC/QA Managers/Supervisors should attend this training
  • Decommissioning options should attend this training
  • CMC Heads/Managers should attend this training
  • Formulation should attend this training
  • Research & Product Development Scientists should attend this masterclass
  • Lead Analysts should attend this masterclass
  • Lab Technicians should attend this masterclass
  • Pharmaceutical Consultants should attend this masterclass

KEY TOPICS STABILITY CONDITIONS OF BIOLOGICS EVENT

  • In this training participants will get guidance and Regulation for Stability of Biologics
  • In this training participants will know advantages and Limitations of Accelerated Stability Assessment
  • In this training participants will understand Biologics Degradation by Chemical, Physical and Microbiological Factors
  • In this masterclass participants will understand Biochemical and Kinetic Approaches to Product Stability
  • In this masterclass participants will learn about Packaging vs Product Stability
  • In this masterclass participants will understand Analytical Methodology for Stability Assessment
  • In this masterclass participants will get knowledge about The Role of Excipients in Stability of Biologics
  • In this masterclass participants will know about Transport and Shipping Impact on of Biologics Stability and Shelf-life

KEY TAKEAWAYS PRODUCT STABILITY OF BIOLOGICS

Understand

  • How to apply ASA to predict your product stability
  • How to improve the stability by picking the right excipient
  • Degradation of biologics by chemical, physical and microbiological factors
  • Bracketing and matrixing to improve your product stability

Learn

  • About guidance and expectations for product stability protocol
  • To identify proper analytical methods for stability assessment
  • How to find the correct packaging for biologics with low stability
  • About acceptation of reduced stability data for new formulations

Gain

  • A comprehensive overview on stability and shelf-life regulatory landscape
  • Harmonized ICH stability guidelines: Q1A-F and Q5C
  • Requirements for stability testing in Climatic Zones I-IV
  • A contact with key leaders and regulatory authority to build up your network

Registration Fee


€2496


Per Participant


About Amsterdam

Amsterdam is the Netherlands’ capital, known for its artistic heritage, elaborate canal system and narrow houses with gabled facades, legacies of the city’s 17th-century Golden Age.

Start Time

9:00 am

May 24, 2019

Finish Time

5:00 pm

May 25, 2019

Address

Munich, Germany

Our Facilitator