Product Stability and Expiry Dating - Integrating the Program into the Product Life Cycle from Inception through Commercial Operations and Latest FDA, EMA & ICH Regulations & Guidance
Live, Interactive Training Webinar
Date: Available Live On-Demand
Instructor: Peter Calcott Ph.D. Biography>>>
Date: Available Live On-Demand
All regulatory bodies require you to conduct stability studies of your product and active pharmaceutical ingredient to develop recommended storage conditions and expiry dating prior to approval of the product for commercialization. ICH even devotes several of the Q series to this topic. In spite of this, many companies appear to have problems in this area as evidenced by an increase in Warning Letters from FDA and observations by European inspectors at technical meetings. These companies are failing to follow several key requirements defined in the regulations. This presentation will prevent you from falling into this trap.
A fully integrated stability program, well thought out and executed, can add much more value to your product development and realization program than simply following the check the box approach of requirements in the ICH documents. For instance, the early degradation studies can lead to a body of knowledge that can lead to improved formulations and presentations. Further a well executed program can lead to more efficient transportation and storage recommendations. These early studies can lead to more robust change control when you choose to make significant changes to your processes and product. The program, using risk based approaches, can lead to better decision making all along the development process into commercial operations and beyond.
This live training webinar will provide valuable information walking you through the life cycle of product development from inception through the life of the product in commercial operations and demonstrating where the stability program can add most value. The live discussion will include the limitations and assumptions you must make at the various stages and how to manage the ever changing climate of knowledge and risk for the product and ultimately, your patients or customers. By understanding the challenges at each stage you will be able to assess how well your program is functioning to add value to your operations or whether it is a check the box activity adding little value.
-How to maximize the benefit of your program by integrating it into the product lifecycle.
-How product stability knowledge increases during development leading to product definition and consistency.
-The three phases of product stability studies and how to streamline them.
-How to perform product degradation studies and choose formulations and presentations.
-How to develop recommended storage conditions and shelf life during clinical phase.
-What is needed to file and assure consistent shelf life in commercial operations.
-How to interpret the regulatory requirements in the 21st Century.
-Why investing in a rugged stability program pays rewards in the product lifecycle.
-How other companies fail to meet the agency requirements in their operations so you do not have to repeat them.
Regulations that will be Covered: Each country has its own specific sets of regulations. Below are citations from ICH and examples of regulations that are applicable to the inspection and response processes and philosophy:
Code of Federal Regulations 21 sections 210, 211 for Biological products and Drugs and 600 series for Biologicals in addition for USA.
EMA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU.
International Conference on Harmonisation Quality Series Q1 through Q11 for USA, EU, Japan and other countries with an emphasis on ICH Q1, Q5, Q7.
Webinar outline and time breakdown:Time*
|9:15 AM||Log In Period|
|9:40 AM||What is the purpose of the stability program,|
|What do the regulations call for in US, EU and ROW,|
|Early Degradation studies and presentation choice,|
|Challenges in clinical manufacturing and determining shelf life,|
|Building your dossier for first in human,|
|10:40 AM||Protecting the patient when knowledge is sparse - using risk management,|
|Integrating new knowledge into your stability program during clinicals,|
|Developing a robust submission for licensure,|
|Confirming shelf life in commercial operations,|
|Using your stability data for optimizing product usage in the marketplace,|
|Where do companies go wrong so you do not have to,|
|11:30 AM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance Personnel
- Quality Control Personnel
- Supply Chain and Logistics Managers
- Regulatory Affairs Professionals
- Process Development Scientists and Management
- Manufacturing Management and Scientists
- Senior management and executives
Instructor: Peter Calcott Ph.D.
Peter H. Calcott, Ph.D. is President, Calcott Consulting which is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance and enterprise e-solutions. He is also an Academic Program Developer for the University of California, Berkeley’s Biotechnology and Pharmaceutics Postgraduate Programs. Prior to this he was VP at the executive team level at PDL BioPharma where he was responsible for development and implementation of Quality & Compliance strategy across the corporation… Full Bio>>>
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