Establishing a Product Stability Testing Program

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

Understand How to Adhere To All the Regulatory Requirements and Implement All Good Practices in Your Product Stability Testing Program

Each drug product may be unique due to different components, and this is a known fact. The chemical and physical properties of active pharmaceutical Ingredients (APIs), manufacturing methods and procedures, the excipients, formulations, storage conditions, containers and closers and the stability of the product, etc. make them all the more unique. In pharmaceutical industry, we are required to establish requirements for the expiration and stability on a drug product. The requirements are to assure that the date is appropriate as required by the current good manufacturing practice (CGMP) for finished pharmaceuticals.

This conference by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, is intended to discuss regulatory requirements and good practices to establish a product stability program. In particular, you will know how to present FDA-compliant practices in adequately implementing regulatory requirements for expiration dating and stability testing program depending upon product types.

Within 60 minutes, you will know why should firms consider and implement the good practices, and remain compliant to recommendations of FDA, so that they can avoid FDA enforcement actions proactively with much awareness. Join the session to know the current view and perspectives of FDA on the product stability testing program.

Why Should You Attend:

This product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.

Session Highlights:

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

You will also get answers to the following tough questions:

  • For a medical device that has storage label of 15-30°C; Are stability studies at 15°C and 30°C or 25°C study sufficient?
  • For a reconstitution study; product has an assigned expiration of 24 months; do I need to do reconstitution at 12 months (6, hours, 12 hours and 24 hours) and at 24 months (6, hours, 12 hours and 24 hours)?
  • What is the accelerated storage for a product with real time storage of -20°C±5C?
  • Is it an industry’s practice to do study one year past expiration?
  • If the regression predicts failure before product expiration, what is the next step to do in stability?

Who Should Attend

  • Healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Laboratory Personnel
  • R&D Professionals
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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