Water production systems represent one of the most critical utilities in the biopharmaceutical industry. These systems are the key to compounding product, manufacturing ingredients, cleaning of the equipment and manufacturing facilities for drug production operations. This presentation will discuss the characteristics of water systems and how to ensure the system is properly validated. The discussion will focus on applying the principles outlined in the proposed FDA guidance on Process Validation issued in November 2008.

We will address the activities which should take place during the design and development of the water system for the biopharmaceutical manufacturing operation as the first step in validating the system. Then we will address the appropriate activities which should take place during the implementation and qualification stage. The discussion will consider verification activities as well as Performance Qualification (PQ) and how to develop the appropriate protocols, design the correct tests, and define the proper acceptance criteria to ensure the system is qualified. We will then consider the protocol execution phase and how to ensure that the system is fit for the intended use. Finally, we will review the appropriate activities to continually verify and ensure the system remains in a validated state through conducting environmental monitoring and applying change control.

By participating in this presentation you will learn:

• What the applicable regulatory requirements are?
• What are the appropriate design steps and the resulting documentation?
• How to qualify the water system and what the protocols would look like?
• How to define the acceptance criteria?
• What constitutes continued verification and how to maintain the validated state?
• Monitoring, statistical trending, and review of critical data to verify proper control of the required water properties.
• Using the data from monitoring to assess the effect of seasonal variations.
• Using data gathered during the continued process verification to improve and/or optimize the systems.

At the end, Dr. Amer will field your questions live on the phone. You will hear all questions and answers from all participants of this seminar.