Cost-Contained Regulatory Compliance: For the by Sandy Weinberg

By Sandy Weinberg

This booklet courses the reader via FDA law instructions and descriptions a complete procedure for price relief in regulatory affairs and compliance. This e-book explains six options to cost-effectively agree to FDA laws whereas protecting product protection and enhancing public entry via expense controls. It offers necessary and functional counsel via case experiences from pharmaceutical, biotech, and clinical gadget industries.

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For all classified systems, subsystems, or components: a. High Risk: Complete all the requirements to define the components of a Comprehensive Validation Study. b. Medium Risk: Complete only the requirements a, b, d, e, and h to define the components of a Comprehensive Validation Study. c. Low Risk: Complete only requirements e and h to define the components of a Comprehensive Validation Study. Note that this SOP not only is designed to provide a clear definition of requirements, eliminating ambiguity, but also utilizes a Risk Assessment concept to further limit regulatory costs.

1 A (European) manufacturer of a new design of plastic condoms developed a technique of nondestructive water testing of all of their condoms, and therefore it eliminated the less accurate spark test. Until expert intervention explained the situation, the USFDA was prepared to demand both the (unnecessary) spark test and the more accurate water test (on at least a sample of devices). The FDA’s lack of expertise would have resulted in significant increased costs without quality value. When a problem occurs, the most cost-effective general strategy is to quickly identify and eliminate the difficulty.

This privacy not only avoids public embarrassment but also provides another opportunity for correction. In a non-auditor model, problems may be identified by the subject department itself and corrected privately, and/or they may be identified by the QA/QC department, and corrected without external display. On the other hand, a subsequent FDA visit that identifies additional problems will rapidly find itself into the press. An auditor can observe a problem, call for its correction, and then re-audit, so the final report only shows (presumably) problem-free findings.

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