Product Stability Testing Program - Designing and Sustaining New and Existing Programs 2015

  • 22 Oct 2015
  • Webinar

Description

Product Stability Testing Program - Designing and Sustaining New and Existing Programs 2015 is a webinar that covers topics such as:

  • General Stability Considerations Applicable to a New Product (i.e. Potency)
  • Introduction of a Stability Testing Plan and Program
    • Applicable Regulation and Requirements
  • Sample Size
    • Handling and Analysis of Samples
    • Sampling Plan
  • Storage Conditions
    • Container Closure Requirements
    • Shelf Life Duration of Studies and Expiration Dates
  • Analytical Testing Considerations
    • Criticality of the Choice of Test that are Stability Indicators
    • Quality Control Release Assays and Methods
    • Method Attributes
    • Choice of Methods with Meaningful Data or Stability Indicator
    • Method Attributes
  • Stability Schedule (Suggested Schedules for Conducting Stability Studies)
    • Stability Tests
    • Pre-approval and Post Approval Studies
    • Accelerated Temperature Studies
    • Reformulated Products
    • Suggested Time Points and Expiration Dates Based on Testing Time Points
    • Test Schedule Information
    • Liquid and Semi-solid Types Products Suggested Test Schedule
    • Solid Dosage Forms Suggested Test Schedule
    • Temperatures of Studies Based on the Product Type
    • Reconstituted Products Suggested Test Schedule
    • Elevated Temperature
    • Room Temperature Studies
    • Freezing Temperature
    • Refrigeration
    • Special Humidity Considerations
  • Stability Testing Data Management and Trending
    • Expiration Dating Extrapolation Using Data
    • Trending Data
  • Stability Testing Protocol Design
    • How to Design a Protocol and a Report
  • Manual versus Automated Data Management
    • Advantages and Disadvantages

Product Stability Testing Program - Designing and Sustaining New and Existing Programs 2015 is intended for attendees from pharmaceutical, biotechnology or medical device industries:

  • Senior Management
  • Quality Control Analyst and Management
  • Shipping and Distribution Personnel
  • Manufacturing Associates and Management
  • Regulatory Affairs
  • Stability Testing Department Personnel and Management
  • Process Design Personnel and Management
  • Quality Assurance Analyst and Management
  • Drug Packaging Personnel and Management

Past Events

Important

Please, check "Product Stability Testing Program - Designing and Sustaining New and Existing Programs" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device, Pharma
Science: Life Sciences & Biology
Technology: Biotechnology

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