John N. Zorich

Confidence-Reliability Calculations and Statistically Valid Sample Sizes

Next, detailed descriptions are given for how to calculate confidence/reliability for data that is either pass/fail (i.e., "attribute" data), normally-distributed measurement data, non-normally distributed measurement data that can be transformed into normality, or non-normally distributed measurement data that cannot be transformed into normality.

Anna Longwell

Customer Interactions: Law, Policies, Ethics

The proliferation of legal requirements (law and regulation) governing the financial relationships between medical product companies and the doctors who order their products has led to what can only be described as a tangled mess. Many device companies have had to add personnel, or employ expensive consultants in order to have a hope of complying.

Lawrence F Muscarella  PhD

Solutions for Improving Infection Prevention in the Endoscopy Suite

This lecture focuses on the contribution of quality to patient safety and the practice of cost-effective medicine. Failure to properly clean and disinfect GI endoscopes and their accessories has been directly linked to disease transmission, with associated patient morbidity and mortality, increasing a GI endoscopy suite's legal exposure.

Albert A. Ghignone

The FDA Drug Development Process

This webinar provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations.

Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

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Denise Mainquist

PCI DSS: Tips and Trends for 2010

Compliance to the PCI DSS can be an overwhelming task in the beginning. The requirements are specific and if your organization has not had an information security program in place, there may be a lot to do to meet minimum compliance requirements.

Melinda Allen

Webinar on Allergen control

Allergens under regulatory control are limited to 8. However, they take on many names and forms. Identifying and avoiding these allergens are an important strategy for manufacturers as well as consumers.

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