Cost-Contained Regulatory Compliance: For the by Sandy Weinberg

By Sandy Weinberg

This ebook publications the reader via FDA rules guidance and descriptions a finished method for fee aid in regulatory affairs and compliance. This ebook explains six innovations to cost-effectively conform to FDA laws whereas preserving product protection and enhancing public entry via price controls. It offers priceless and functional suggestions via case reviews from pharmaceutical, biotech, and clinical gadget industries.

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All employees should be carefully trained to answer FDA questions truthfully and accurately. With an outside auditor, however, that honesty is supplemented by the volunteering of additional information beyond the narrow limits of a specific question. The result is a more thorough and accurate picture than that obtained by an FDA investigator. The private nature of the audit also affects the scheduling of the event. An FDA visit is scheduled at the convenience of the agency; it does not account for vacation schedules, production plans, quarterly reports, or other events that may have an influence upon the smooth running of the rest of the organization or its employees.

Finally, a QbD approach provides a risk assessment that identifies the appropriate focus of the laboratory operations and provides a defensible justification for tolerances of variations. The effect may be (a) extended life of otherwise arbitrarily discarded reagents, (b) useful data from slightly contaminated samples, and (c) a more efficient laboratory operating procedure. 11 Quality by Design is a conceptualization rapidly gaining traction in the biomedical industries, led by an FDA initiative to reduce costs, increase quality control, and shift the primary responsibility for quality assurance firmly onto the industry.

In the model, the Design Space is represented by “UP,” the measurement of the depth of understanding of the process and the associated design space. The better a process is understood, and the greater to which the range of accepted values have been successfully tested, the higher the UP value. Process Analytical Technology (PAT) is a conceptual approach to quality assurance calling for increased reliance on monitoring throughout a manufacturing (or other) process rather than dependence on a final-stage quarantine and testing approach.

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