Quality, Compliance and Regulatory Best Practices

Best Practices, LLC has conducted extensive research in the field of Quality, Compliance and Regulatory. Browse through and sample our published Quality, Compliance and Regulatory research in the topics below:


 
Benchmarking Quality in the Biopharmaceutical & Medical Device Sector
Pharmaceutical and medical device companies allocate a considerable amount of resources to ensure their products meet quality standards at every stage of the product life cycle, from R&D and product development through manufacturing, sale, and post-market support. Consequently, Quality leaders face a balancing act between managing costs; ensuring product quality and compliance; and adding value for patients and health care providers. Best Practices, LLC undertook benchmarking research to probe how Quality organizations can move beyond simply ensuring product safety and compliance and add enterprise value. In particular, this report provides benchmarks around integrating quality into the organization’s strategic focus and priorities; structure of Quality groups; use of digital technology; managing quality for GLP, GCP, GMP and pharmacovigilance. It also provides benchmarks around Quality staffing and spend levels; supplier management; audit and risk evaluation; CAPA; risk management and outsourcing.

The Quality Function: Structures, Staffing and Execution
Knowledgeably improve the quality function of your company by using the benchmark metrics, managerial observations and benchmark study trend analysis in this report. The U.S. Food and Drug Administration has recently cited manufacturers for a variety of deficiencies in quality control, such as data handling, computer system validation, and manufacturing review processes. These deficiencies have resulted in extraordinary attention being placed on companies’ quality functions. Missteps in this area can potentially lead to manufacturing shutdowns by the U.S. government, severely impacting product launch, supplies, patient health, and corporate profitability. Best Practices, LLC studied the systems, approaches and practices of seven pharmaceutical and medical device companies known for exceptional quality execution. By applying the knowledge obtained from these companies, your company can dramatically improve it's overall quality function.

 


 
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