John N. Zorich

Statistical Analysis of Gages (Metrology)

The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage Linearity, and Gage Bias.

Albert A. Ghignone

21CFR Part 58 - The Good Laboratory Practices (GLP) Regulation

FDA regulates the nonclinical safety testing of Drugs, Biologics and Medical Devices under a regulation called The Good Laboratory Practices (GLP)regulation. This webinar will address the reasoning for and the requirements of the GLP regulation. Every section of the GLP (Subparts A - Subpart K) will be addressed. FDA's "umbrella" approach to the GLP will also be discuss and FDA interpretations of the GLP reviewed.

John E Lincoln

Design Controls - Requirements for Medical Device Developers

This webinar will discuss the 9 required elements of a Design Control System. It will consider different methods of implementation, and expectations of the U.S. FDA, proven by documentation.

David R. Dills

FDA's Update on Medical Device Labeling Changes

FDA recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a causal association between the product and a safety signal is present.

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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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