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This Year in Quality, Part One

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A new year always brings new hope, new plans, and new perspectives. While looking ahead is the most direct route to progress, looking back is essential to understanding the present. After all, the past creates the consequences that will shape the future.

Comparing Pharmaceutical Continuous Monitoring Systems: Part 2

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Ken Appel is the manager of regulated industries for Veriteq.

Comparing Pharmaceutical Continuous Monitoring Systems: Part 1

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Ken Appel is the manager of regulated industries for Veriteq.

T

Food Safety: Challenge or Opportunity?

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Food safety standards are becoming increasingly stringent.

When All Else Fails, Lower Your Standards

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My definition of “specification” is rather simple: It’s a promise.

Savvy Compliance Strategy, Part IV

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21 CFR Part 11: Auditors Are at Your Door

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On July 8, the Food and Drug Administration (FDA) announced an initiative “… to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 Guidance for Industry Part 11, Electronic Records; Electro

One-Year Exemption from FDA Inspections Possible

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Medical device manufacturers may gain a one-year exemption from Food and Drug Administration (FDA) inspections if their establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members usin

Congress Can Wait… But the FDA Won’t

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For quite some time, polls have indicated that public approval for Congress remains at an all-time low. Congressional gridlock is difficult to watch for U.S.

Savvy Compliance Strategy Can Improve GMP

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The compliance department’s primary function is to ensure that the company complies with all applicable regulations, rules, and laws. Regardless of the industry—life science, energy and utilities, or financial services—this is a universal mandate.

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