Our speaker for this event is Wai Wong, Vice President of PharmaTech Associates.
With the issuance of the FDA’s guidance documents defining a more scientifically driven product development and quality paradigm, the philosophy and approach to validation must be revisited. New programs within the FDA such as Process Analytical Technology (PAT) and the Pharmaceutical Quality Assessment System require a much more intensive scientific argument as a premise to validation. One possible solution is to adopt the principles classically utilized within operational excellence approaches such as six-sigma to lay the foundation for a more effective approach to validation and process stability.

This presentation will discuss the principles classically employed within validation and process development and describe a new approach that embraces the basic elements of Risk Management and Quality by Design as defined within ICH Q8 and 9 and the ASTM E55 guidance as part of a new approach to Validation. If you have found validation to be a bottleneck in your organization or found difficulties as a quality or validation professional being asked to do more with less, this presentation will help with the establishment of a defensible validation approach.

We are planning to enhance networking opportunities at our upcoming meeting on November 20 at Scott's by convening in the bar for a "Happy Hour" prior to starting the meeting. Plan to arrive early at 5:30 to get the maximum benefit from this networking opportunity.

We also ask that you register early. The restaurant requires a final count on Monday prior to the meeting. We do our best to accommodate late registrations but it does complicate the process.

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