ISPE is proud to announce our fourth and final Keynote speaker for this year's Annual Meeting

J. David Doleski, Acting Supervisory Consumer Safety Officer, Office of Manufacturing and Product Quality (OMPQ), Division of Good Manufacturing Practice Assessment, FDA Pharmaceutical Manufacturing: Current Developments and Trends Involving Inspections, CGMP Compliance, and Regulatory Actions



Mr. Doleski will discuss current priorities and initiatives within CDER's Office of Compliance pertaining to pharmaceutical quality. He will describe some of the areas of greatest focus for inspection and enforcement activities. Case studies involving recent manufacturing issues will illustrate some areas of increased attention by regulators. Trends in pharmaceutical manufacturing will be discussed, along with the impact on regulators, manufacturers and patients.

Plus! Education Sessions

Mix and match sessions from any of the following tracks to maximize your value and customize your education experience! View the Conference website for full eduction track descriptions and event details.

Training Courses

Enhance your career by attending one of the training courses offered.

Networking Events

Choose from a variety of networking events including the COP Night Reception and Dinners, the Networking Dinner hosted by ISPE Young Professionals, Tuesday Party and more! Most of these events require pre-registration, so reserve your spot today!

Pre-Order Both and Save Big on the New PQLI Guide Series!

ISPE Members who register for Annual Meeting can purchase both guides in the series for the reduced rate of $145/&euro115—a savings of $145!* Part 1: Product Realization using QbD, Concepts and Principles
Part 2: Product Realization using QbD, Illustrative Example Pre-order your copy here.

* Discount applies to ISPE Members only. Guides may be purchased onsite or online. If you cancel your Conference registration after purchasing the PQLI Guide Series, you will be charged the full price of the Documents. Offer is good until 16 November 2011. All materials are anticipated to ship by 10 November.
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