Product Stability Testing Program – Designing and Sustaining New and Existing Programs



This life science 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.

Why Should You Attend:
To avoid mistakes and misinterpretations while designing a new drug stability testing program or while modifying existing ones, it’s best to have a clear knowledge of the regulations and guidelines stipulated by the FDA, 21 CFR and other regulatory bodies.
This session will help the attendee gain a better understanding of the requirements of the FDA’s drug stability guidelines stipulated for new, existing and modified drug products with an existing or new IND or NDA submission.
This webinar will also provide detailed requirements applicable to the FDA and 21CFR 514.1(b)(5)(x) expectations which states that “an applicant should submit data from stability studies that have been completed as well as information about studies that are underway to substantiate the request for a specific expiration date and provide information on the stability of the drug products.” Consequently, it is important to have clarity and understanding of how to apply this regulation prior to the initiation of a new product stability testing program which includes the protocol design, testing, storage, data management, trending and expiration dating extrapolations and expectations for products in a new or existing IND or NDA application process.

Areas Covered in the Webinar:
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
Freezing Temperature
Special 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

Note: Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.

Ad Reference ID: 24955cdb3e2d8272

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