FDA Compliant Stability Program In Changing Environment

From Tuesday, March 08 2011 - 8:00am to Thursday, March 10 2011 - 5:00pm (Eastern Time) Register Here

Registration Fee

Before February 11th: $1050
After February 11th:: $1450


Marriott Hotel

Bethesda, MD

The information will be available soon.




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This event will focus on the FDA's expectation and current thinking in today's global environment for pre and post approved products. Developing successful Stability testing strategies manage resources and implement best practices.
The pressure to ensure the regulatory requirements are met for stability testing is high within industry as they focus on cutting budget and avoiding recalls. Establishing an effective and efficient stability testing program is key to your success.
This event is focused on key challenges you are facing today and how to utilize the best procedure to deliver high quality data and combat your issues.

Presentations title:

FDA's role in the development of Stability program and its respective guidelines

Stability data management
Susan Cleary, Novatek International

Bracketing and Matrixing
To discuss the implication and efficiency / savings of using these techniques during study design
Patrick Bell, Pfizer Consumer Healthcare

Study design for a global market, climatic regions

Challenges and Successes in Implementing an Electronic Stability Management System for Global Reporting Purposes
Susan Cleary, Novatek International

I. Selecting the Right Stability System
• Software (OTS, Configurable OTS, Customized)
• GAMP Validation approach based on software type
• Vendor Audit
II. Piloting the Stability System
• Training
• Configuration requests
• Control logs
• User acceptance testing
III. Validating the Stability System and Meeting 21
CFR part 11.
• Documentation
• SOPs
• Risk Assessment
IV. Applying the Stability System to Assist in Reporting
Stability Study Data
• Reports
• Statistics
• What makes a complete report package

Risk Assessment

Implementing Modern, Efficient and Compliant Quality Systems
Melissa Morandi, Acceleron

Creating Modern Quality Systems compliant to QSR and ICH
Implementing new Quality Systems and major changes to current Quality Systems
Key areas of focus in Quality Systems
Streamlining current Quality Systems
Preparing Quality Systems for inspection
Combining Drug and Device Quality Systems
Evaluating the compliance and efficiency of your Quality System
Common pitfalls in Quality Systems
How to stay compliant with limited resources
Transitioning to Electronic Quality Systems

Extractables and Leachables
Dr. David Lin, Biologics Consulting Group

Auditing your stability Program
John O'Neill, Boston Scientific

John O'Neill, Boston Scientific

Unique Considerations for Stability Testing of Biological Components in Medical Devices
Dr. Nadine Ritter, Biologics Consulting Group

Biological products have specific requirements for stability testing based on their complex and heterogeneous macromolecular structure, their sensitivity to physical and chemical stress, and their typically non-linear degradation kinetics. Technical and regulatory elements of stability studies applicable to the biological components of combination medical devices will be presented. Challenges faced in selecting and validating stability-indicating methods to determine the stability profile and shelf life of biologically-based medical devices will be discussed

The use of Pharmaceutical Stability Tools in Medical Device Stability Programs
Laurie Larkin, Synthes USA

I. What is the Changing Stability Environment?
• What is the meaning of "stability" in the context of Medical Devices?
• Outline the pressures inherent in the current FDA Environment.
• Are the pressures different for our northern neighbors?
• How about the EU Environment?
• Recent Stability Regulatory Actions
II. We don't have to re-invent the wheel for Medical Devices. There are Pharmaceutical based tools we can use in Medical Devices to improve the Quality and Robustness of Medical Device Sta ility Studies
• The concept of QbD
• The concept of Stress Testing (Forced Degradation)
• The concept of excursion simulation
III. Other Important Points to Consider
• The concept of intrinsic stability
• Don't forget package stability
• Things Device Companies can miss when they enter the Combination Product Arena

Bonus Material
• FDA guidance based pre-stability points to consider checklist
• Case Studies based on theoretical devices

Statistics in Stability, tools of the trade
Discussions on the application of statistical tools including arrhenuis, p value, data pooling, Dixon test, multiple and single regression

Who Should Attend

• Analytical Development
• Research & Development
• Validation
• Process Development & Control
• Manufacturing/Operations
• Materials management
• Packaging and labeling
• Laboratory quality control
• Regulatory affairs

Industry: Pharmaceutical, Biotechnology, Medical Device

Some of Learning Objectives

Implement common strategies used successfully in the Pharmaceutical industry to define material based family design spaces facilitating a streamlined approach for adding or excluding future family candidates.

Create and implement an efficient Quality Systems to meet QSR and ICH
Streamline an existing system
Focus on most important aspects of Quality System
Measure compliance to Quality Systems
Learn points to consider for electronic systems
Learn points to consider for combining drug and device systems

Location : Bethesda, MD
Contact : info@gbprinc.com

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