Two Day Online Seminar for Designing and Sustaining New and Existing Pharma/Biotech Product Stability Testing Program (October 6-7, 2021) - ResearchAndMarkets.com

The "Designing and Sustaining New and Existing Product Stability Testing Program" training has been added to ResearchAndMarkets.com's offering.

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.

Key Topics Covered:

Day 01 (9:00 AM to 4:00 PM EDT)

Session 1: 9:00 am - 10:15 am

• 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 (I.e. Potency)
• 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: 10:15 am - 11:00 am

• 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

11:00 am - 11:15 am (Break)

Session 3: 11:15 am - 12: 00 pm

• 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.
• Storage Temperature for various types of products.
• Performing an effective sampling plan and utilizing the appropriate sample size for a stability testing program.
• Performing a compliant sample analysis, handling and effecting the appropriate test specification for the product type.

12:00 pm - 1:00 pm (Lunch Break)

Session 4: 1.00 pm - 2: 00 pm

• Topic: 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
• Performing Various Types of Stability Tests such as Reformulated Products, Accelerated Temperature Studies and others.
• Understanding the different Types of Stability Test Schedules Provided by Regulations Based on the following Product Types and Information:

Session 5: 2.00 pm - 3: 00 pm

• 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
• Performing Different Temperatures of Studies based on the product type such as Room Temperature Studies, Elevated Temperature, Refrigeration, Freezing Temperature and Special Humidity Considerations

3.00 pm - 3:15 pm (Break)

3.15 pm - 4:00 pm (Review of Case Studies)

1. Case Study #1 and Suggested Resolution

Day 02 (9:00 AM to 4:00 PM EDT)

Session 1: 9:00 am - 10:15 am

• Topic: 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.
• How to Effectively Handle, Manage Data, Utilize and Perform the Trending of Stability Testing Results and Data.

Session 2: 10:15 am - 11: 00 am

• Topic: 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.
• Choice of methods with meaningful data or stability indicator
• Analytical Assay Test Method Attributes

11:00 am - 11:15 am (Break)

Session 3: 11:15 am - 12: 00 pm

• Using the Laboratory Information Management Systems (LIMS) in a Stability Study Program
• Data Documentation, Entry and Management (Types of Documentation Methods)
• 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 (Manual versus Automated Data Management)
• Advantages and Disadvantages of each type of system
• Types of Stability Test Data Management Software (LIMS) for Stability Test Data Management

12:00 pm - 1:00 pm (Lunch Break)

Session 4: 1:00 pm - 2: 00 pm

• 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
• Common mistakes made during the purchase of some Stability data management software.
• Choosing the best LIMS software programs used for stability test data management.

Session 5: 2:00 pm - 3:00 pm

• 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.
• Understand the different ways of performing statistical analysis of the stability test result data (manual versus automated software).

3:00 pm - 3:15 pm (Break)

3:15 pm - 4:00 pm (Review of Case Studies)

• Review of Case Studies: Issues Encountered by Drug Product Manufacturers Based on a Poorly Designed Stability Testing Program
• 1. Case Study #2 and Suggested Resolution

For more information about this training visit https://www.researchandmarkets.com/r/ft3y04

View source version on businesswire.com: https://www.businesswire.com/news/home/20210726005474/en/