The "Designing and Sustaining New and Existing Product Stability Testing Program" conference has been added to ResearchAndMarkets.com's offering.
New or existing modified drug Stability Testing Program's regulations/requirements stipulated by the FDA, 21 CFR or other regulations may sometimes creating an overwhelming situation based on the type of product that is being manufactured. Hence, some manufacturers of new drug products have made inadvertent mistakes in the design of their new drug stability testing program.
Such mistakes may ultimately delay the new, existing or modified product IND or NDA application process due to the data that was presented to the FDA . It is better to understand, follow and apply the full requirements of a new product stability testing requirement from the onset or to correct an existing stability testing program so as to avoid future pitfalls and delayed IND or NDA submission process by the FDA.
Having produced a new or existing product, knowing the appropriate way to design and perform the stability testing of the new product which is a prerequisite for setting the product's expiration date and possible extension of the expiration date is critical. Some drug product manufacturers have made mistakes in the past whereby a new product that was manufactured appropriately did not have a good stability testing plan or program hence it delayed the product's ability to have an approved IND or NDA submission. A mistake of this sort has also been made by drug manufactures that resulted in a 483 or Warning letter by the FDA. Knowing how to approach the design of a new product stability program at the onset of the new product design or during an existing product testing is important and will save a company time and cost in moving the product to the next phase.
This Virtual Seminar will provide a great resource in understanding the effective way to establish a new or modified product stability testing program.
The focus of this seminar will create a detailed process that will guide the attendees in the right direction in the planning of a new or existing product's stability testing plan, program, protocol, handing and utilizing the data, setting the shelf life as well as the applicable regulatory requirements.
Agenda:
Day 01
Session 1
- General Stability Considerations Applicable to a Product's Stability, Storage Conditions, Sampling Plan and Sample Handling
- Knowledge Base: Attendees will gain an understanding in the following key areas:
- Introduction of a Stability Testing Plan and Program.
- Regulatory guidance associated with the requirements of a product's stability testing program.
- Delineating the program requirement specific to a type of product.
- Applicable Regulation and Requirements.
- Purpose of a Stability testing Program
- General Stability Considerations applicable to a New product
- New product stability indicator tests
- Rationale for choosing the test and impact to the product's shelf life.
- Storage Conditions
- Shelf Life Duration of Studies and Expiration Dates
- Container Closure Requirements
Session 2
- Handling and Analysis of Samples
- Stability Schedule
- Pre-approval and Post Approval Studies
- Stability Tests
- Reformulated Products
- Accelerated Temperature Studies
- Test Schedule Information
Session 3
- The relationship between choosing the right product storage temperature and impact to its shelf life.
- Temperatures of Studies based on the product type
- Room Temperature Studies
- Elevated Temperature
- Refrigeration
- Freezing Temperature
- Special Humidity Considerations
- Container Closure Requirements.
Session 4
- Designing and Conducting Effective Stability Testing Program Using the Suggested Schedules for Various Product Types
- Knowledge Base: Attendees will gain an understanding in the following key areas:
- How to Conduct a Pre-approval and Post Approval Stability Testing Studies
Session 5
- 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
Day 02
Session 1
- Stability Testing Protocol Design, Data Management and Trending. Comparative Analysis of Using a Manual versus Automated Data Management
- Knowledge Base: The Attendees will gain an understanding in the following key areas:
- How to Design an effective Stability Testing Program, Protocol and a Report for a New and Existing Product.
Session 2
- Analytical Testing Considerations, Review of Case Studies
- Knowledge Base: Attendees will gain an understanding in the following key areas:
- How to perform Quality Control Testing, Setting Test Specification and Assay Release Process in a Stability Testing Program.
- Detailed Reasons why the Choice of a Quality Control Test Method, Specific Assays and Tests Specifications are Critical to the Success of a Product's Stability Testing Program and Shelf Life Determination.
Session 3
- Using the Laboratory Information Management Systems (LIMS) in a Stability Study Program
- Data Documentation, Entry and Management
- The Criticality of the Choice of a Stability Test Data Management System used for Data Management.
- Considerations when choosing a Stability Test Data Management System
- Advantages and Disadvantages of each type of system
Session 4
- Understanding the LIMS Stability Module Program and Statistical Analysis Tools
- Understanding the various modules under the Stability Data Management Software in LIMS.
- Best practices when selecting Stability test data (LIMS) Vendor
- The various parts of the Stability test data management software
Session 5
- Using Stability Testing Data to Generate the Product's Expiration Dating or Shelf Life.
- How to Perform the Extrapolation of a Product Shelf Life Using Data from an Ongoing Stability Testing Program
- Great for products in clinical studies.
For more information about this conference visit https://www.researchandmarkets.com/r/2gvl8m
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