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: October 22, 2013
Time: 1:00pm - 3:00pm ET
Instructor: Peter Calcott Ph.D.
Click Here to Register for this Interactive, Live Webinar
All regulatory bodies require you to conduct stability studies on your product and active pharmaceutical ingredient to develop recommended storage conditions and expiry dating prior to approval of the product for commercialization. However, a fully integrated stability program, well thought out and executed, can add much more value to your product development and realization program. 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 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. 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. Based on Warning Letters released by the FDA, it is clear that stability programs in many companies are just not being executed to meet the regulatory agency requirements and not becoming a value added activity to the company.
Learning Benefits:
-How to maximise 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:
Date: October 22, 2013
Time* Activity
| 12:45 PM | Log In Period | |
| 1:00 PM | Introduction | |
| 1:10 PM | 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, | ||
| 2:00 PM | Break | |
| 2:10 PM | 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 optimising product usage in the marketplace, | ||
| Where do companies go wrong so you do not have to, | ||
| Conclusions, | ||
| 3:00 PM | Live Questions & Discussion |
*Please note all times are Eastern 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