Michael Brodsky

Is it Method Verification or Validation, or Just Semantics?

Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005. Unfortunately, the terms are often incorrectly used interchangeably, resulting in confusion and the application of inappropriate or inadequate analytical evaluations.

Casper Uldriks

FDA's Inspection of Foreign Device Manufacturers

FDA inspects foreign manufacturers to assess their compliance with the same manufacturing requirements that apply to U.S. firms. How you and the FDA conduct the inspection can make a huge difference on the outcome. The inspection can have a significant if not disastrous impact on a foreign firm's current and future business in the U.S.

Kim Huynh-Ba

Risk Management for Pharmaceutical Change Control program

Change is inevitable in the pharmaceutical industry. Manufacturing process changes and product changes are common post approval activities. Therefore, managing change is as much a business need as it is a regulatory need for pharmaceutical companies to stay in compliance. It is a process that can significantly impact the efficiency of an organization. This presentation will introduce a risk based approach and procedure with regard to severity, likelihood and detection to manage the change control program.

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.

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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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