Download e-book for kindle: Cost-Contained Regulatory Compliance: For the by Sandy Weinberg

By Sandy Weinberg

This e-book publications the reader via FDA legislation instructions and descriptions a accomplished procedure for rate aid in regulatory affairs and compliance. This booklet explains six recommendations to cost-effectively agree to FDA rules whereas protecting product safeguard and bettering public entry via expense controls. It offers worthwhile and sensible assistance via case reports from pharmaceutical, biotech, and scientific equipment industries.

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Extra resources for Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries

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These advantages, missing in a media in which immediacy is primary and contemplation is an absent luxury, have a tragic limitation. Words crafted during an evolving process are unlikely to reflect the final reality. Writing before concrete decisions have been made, before policies are finalized, and before regulations are established carries the risk of misreport or misinterpretation. The FDA’s “Quality by Design” (QbD) initiative is a prime example of a nebulous, evolving regulatory approach that is just beginning to gel into a key component in regulatory compliance.

Indd 27 2/9/2011 12:24:31 PM 28 CHAPTER 3 PREREGULATORY AUDITS FDA team as independent, expert, experienced, and credible. Operationally defining these characteristics is problematic at best. There are some clear disqualifications. While the auditor can be from the same company to be audited (“internal”) or from outside the company (“external”), the reporting relationship of the auditor must be completely separate from the organizational unit to be audited. That is, an auditor may be a member of the company, but only if he or she reports outside the chain of command of the audited division.

Indd 43 2/9/2011 12:24:32 PM 44 CHAPTER 4 QUALITY BY DESIGN and cybernetically controlling those processes, and (c) a risk-based prioritization and interpretation of those measurements. Secondly, QbD is logically consistent. It provides a rational framework for controlling quality in production, search, laboratories, and other requirements, with a reasonable and defensible system of tolerances and permissible variants. QbD makes good sense for the management of an automated laboratory: Understand the processes involved, measure the performance of those processes, and interpret those measurements in a risk construct.

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