JVT Journal Articles
Vol. 17, Issue 4, Nov 2011

John A. Wass
The following key points are discussed: Design of experiments (DOE) consists of three basic stages: screening (to identify important factors), response surface methodology (to define the optimal space), and model validation (to confirm predictions). A critical preliminary step in the screening stage is for subject matter experts to identify...
The following key points are discussed: Preparation is a key element in assuring a successful audit. Specific audit personnel must be identified. These include the primary audit contact, audit coordinator, and other personnel with specific audit-related responsibilities and functions. Activities that are always required for audits must be...
Paul L. Pluta, Ph.D.
The following key points are discussed: Validation managers identified problems with original validation data as one of their most troubling problems. These problems also included original data supportive to validation projects.
John E. Lincoln
The following key points are discussed: The US Food and Drug Administration issued 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device–Draft Guidance on July 27, 2011. FDA holds the manufacturer responsible to make the 510(k) determination aided by this further clarification in the guidance.

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