Two Day Online Seminar for Designing and Sustaining New and Existing Pharma/Biotech Product Stability Testing Program (October 6-7, 2021) - ResearchAndMarkets.com
Performing an effective sampling plan and utilizing the appropriate sample size for a stability testing program.
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/