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