Product Stability Program - from Drug Development, Clinical Trial and in to Market : Comprehensive Course (4 Modules)

The main purpose of stability program is to evaluate a shelf life for a product to enter a market and before that determine a safe stability profile during clinical trial. There are many guidance which showcase the best practices how to achieve a successful stability program and then specific guidelines are formulated for a particular product ex – ICH regulatory guidance, QBD, PQS, QRM.

It is very important to have a clear understanding of guidelines and regulations pertaining to stability program to avoid mistakes and hence we have created this comprehensive courseware to enable companies understand the requirements of the FDA’s drug stability guidelines and understand how to design a product stability testing plan applicable to new or modified products in the pharmaceutical, biotechnology and medical device industries. Understand the ICH regulatory guidance, analytical methods requirements, how to interpret the data generated by the stability programs, the stability protocol content and format, specialty stability studies. It will also discuss requirements, design and implement leachable stability programs in particular.

Do not delay any more. Hurry ! Get the whole set at 45% flat discount.

All Modules:

Module 1: Product Stability Testing Program - Designing and Sustaining New and Existing Programs
Module 2: ICH Stability Requirements and Challenges
Module 3: Preparing Stability Protocols for Development and Commercial Products
Module 4: Stability Programs for Leachable Impurities

Who Will Benefit:

• Drug Development Professionals
• Stability Managers
• CMC Analytical Managers
• Manufacturing
• Quality Assurance
• Regulatory Affairs
• Program Management
• Technical operations
• Supply chain

Module 1 : Product Stability Testing Program - Designing and Sustaining New and Existing Programs

Areas Covered in the Webinar:

1. Introduction of a Stability Testing Plan and Program
1. Applicable Regulation and Requirements
2. General Stability Considerations Applicable to a New Product (i.e. Potency)
3. Storage Conditions
1. Shelf Life Duration of Studies and Expiration Dates
2. Container Closure Requirements
4. Sample Size
1. Sampling Plan
2. Handling and Analysis of Samples
5. Stability Schedule (Suggested Schedules for Conducting Stability Studies)
1. Pre-approval and Post Approval Studies
2. Stability Tests
3. Reformulated Products
4. Accelerated Temperature Studies
5. Test Schedule Information
1. Suggested Time Points and Expiration Dates Based on Testing Time Points
2. Solid Dosage Forms Suggested Test Schedule
3. Liquid and Semi-solid Types Products Suggested Test Schedule
4. Reconstituted Products Suggested Test Schedule
6. Temperatures of Studies Based on the Product Type
1. Room Temperature Studies
2. Elevated Temperature
3. Refrigeration
4. Freezing Temperature
5. Special Humidity Considerations
7. Analytical Testing Considerations
1. Quality Control Release Assays and Methods
2. Criticality of the Choice of Test that are Stability Indicators
1. Choice of Methods with Meaningful Data or Stability Indicator
2. Method Attributes
3. Method Attributes
8. Stability Testing Protocol Design
1. How to Design a Protocol and a Report
9. Stability Testing Data Management and Trending
1. Trending Data
2. Expiration Dating Extrapolation Using Data
10. Manual versus Automated Data Management
1. Advantages and Disadvantages

Module 2 : ICH Stability Requirements and Challenges

Areas Covered in the Webinar:

• Background and Overview of ICH Q1
• What are the requirements for stability programs
• What are the analytical method requirements, what needs to be measured
• Stability indicating methods – what are they?
• Designing Stability Studies
• Standard programs vs matrixing vs. bracketing
• ANDA stability requirements
• Data Analysis
• Tracking and trending
• OOS vs OOT
• Setting specifications and shelf life

Module 3 : Preparing Stability Protocols for Development and Commercial Products

Areas Covered in the Webinar:

• Creating stability protocols
• Shipping protocols
• ICH and FDA specific requirements
• Updating the FDA with data during development and commercial phases
• Changing expiry dating with more data

Module 4 : Stability Programs for Leachable Impurities

Areas Covered in the Webinar:

Background and Overview of Leachables

• What are extractables and leachables
• Where do they come from
• Why is there concern

How to Design and Implement Leachable Stability Programs

• What are the requirements for leachable stability programs
• How to develop and validate methods for use in leachable stability programs
• Drug product impurities vs. leachable impurities
• Common pitfalls associated with leachable stability programs

Instructors:

Charity Ogunsanya, is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO) and medical device/IVD companies.
Dr. Wayland Rushing is a technical expert in chemistry, manufacturing and controls (CMC) program design, analytical development and regulatory submissions. Over his 15-year career, he has led CMC development programs for a wide array of biopharmaceuticals, including parenterals, inhalation drugs, and other pharmaceuticals with complex delivery systems.
Peggy J. Berry, MBA, RAC, is the president and CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was vice president of regulatory affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department.

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