Pharmaceutical & Biopharmaceutical Stability 2011

  • 19-20 Oct 2011
  • Sheraton Montreal Airport Hotel, Canada

Description

Pharmaceutical & Biopharmaceutical Stability 2011 is a conference that covers topics such as:

  • Stability Protocol Development to Meet International Product Registrations
  • Regulatory Requirements of Stability Testing
  • WORKSHOP Operational Excellence In Stability Storage Operations
  • Designing Stability Program for Combination Products
  • Herbal Medicinal Products - The Challenges of Stability Testing
  • Challenges in Stability Testing - A European Perspective
  • How to deal with Out of Specification Results (OOS) and Trends of Stability Data
  • Development of Analytical Methods for Stability Testing
  • Statistics in the Interpretation of Stability Results
  • Successful Outsourcing of Stability Testing
  • Using Stability Test Results for Expiry and Retest
  • Calculation of Stability and Release Limits
  • Follow-up Stability Testing
  • Investigation Related to Stability Results
  • Defining Bracketing and Matrixing (ICH Q1D)
  • Post-Approval Changes (Variations) Requiring Stability Data
  • Specific Stability Requirements for Biopharmaceuticals
  • Planning Stability Testing to Cover a Product Lifecycle
  • Drug Stability: Where to Draw the Line?
  • Microbiological Testing during Stability Studies
  • CASE STUDY Establishing a New Stability Program

Pharmaceutical & Biopharmaceutical Stability brings together executives and managers from Biopharmaceutical, Pharmaceutical, Biotech and Allied industries with responsibilities in Analytical R&D, Stability, Quality Assurance, Quality Control, Product Development, Raw Materials Testing, Chemistry, Manufacturing and Controls (CMC), Formulation, Pre-Clinical Research, GMP/GLP Compliance, Validation, Regulatory Affairs, Training, Product Submission, Contract Laboratories, Documentation and Technical Writing and Contract Manufacturing.

Past Events

Important

Please, check "Pharmaceutical & Biopharmaceutical Stability" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Healthcare, Medical device, Medical laboratories, Pharma
Technology: Biotechnology

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