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

Dublin, Aug. 25, 2021 (GLOBE NEWSWIRE) -- The "Designing and Sustaining New and Existing Product Stability Testing Program" training has been added to ResearchAndMarkets.com's offering.

This Virtual Seminar will help the attendee gain a better understanding of the requirements of the FDA's Drug Stability Guidelines that is stipulated for new, existing and modified drug products that have an existing or new IND or NDA submission.

This Virtual Seminar will also benefit people within the Pharmaceutical, Biotechnology or Medical Device industries that are currently have a stability testing program but do not know how to maximize the use of their data for extending their product's expiration dating.

This Virtual Seminar will provide the detailed requirements applicable to the FDA's 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" FDA's Guidance for Industry.

For this reason, 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.

Key Topics Covered:

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

Session 1: 9:00 am - 10:15 am
Topic: General Stability Considerations Applicable to a Product's Stability (I.e. Potency), 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 (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)

• Review of Case Studies: Issues Encountered by Drug Product Manufacturers Based on a Poorly Designed Stability Testing Program

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

• 2. Case Study #3 and Suggested Resolution

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

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