The 2-day seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics. Basic vocabulary and concepts are then reviewed and discussed. The flow of subsequent topics over the 2 days is as follows: • How to calculate confidence interva...

FDA's and the Customs and Border Patrol Service (CBP) has become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that thei...

FDA inspections are typically the starting point for the sequence of enforcement actions, since serious violations discovered at inspections will often result in Warning Letters, which in turn, if not properly responded to, can turn into seizures, injunctions, prosecutions, or reca...

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressi...

This webinar explains the issues and techniques that regulators may use when investigating your water systems for "GMP flaws". More than likely, even the most quality-conscious organization has some water system "skeletons" in their closets, perhaps unwittingly. These "skeletons" o...

The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.

Next, detailed descriptions are given for how to calculate confidence/reliability for da...

Intentional contamination or adulteration of food is a reality. We will review some examples of the dire consequences of adulteration ostensibly for economic gain This webinar will also discuss the potential threats of using food as biological weapon and the actions food companies ...

Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors.

This webinar a...

This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health.

Your goal ...

The webinar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing esp...