Jeff Kasoff

Design Control for Medical Devices

Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction.

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.

Thomas E. Colonna

FDA's current thinking on cGMP compliance for Phase I Investigational Drug and Biologic products

Because certain requirements in 21 CFR part 211, which implement § 501(a)(2)(B) of the FD&C Act, were directed at the commercial manufacture of products typically characterized by large, repetitive, commercial batch production (e.g., those regulations that address validation of manufacturing processes (§ 211.110(a)), and warehousing (§ 211.142)), they may not be appropriate to the manufacture of most investigational drugs used for phase 1 clinical trials.

Lou Angelucci

Similarities and Differences Between an FDA and MHRA Audit

Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.

Robert J. Russell

European Union Filings and Registrations

This session covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.

Albert A. Ghignone

FDA Acceptance of Foreign Clinical Studies Not Conducted Under An IND

This webinar will discuss FDA's criteria for acceptance of foreign clinical trials whether conducted under an FDA submission or not conducted under an FDA submission. Clinical research is becoming increasingly global. FDA recognizes Sponsors may decide to use clinical data that is obtained from foreign sites to support clinical investigations and/or marketing approval in the USA. Some Sponsors may even seek to rely solely on foreign clinical data for an FDA investigational or marketing application. This webinar will review criteria for FDA acceptance of foreign clinical studies/data.

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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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