Full Circle Consulting
EMMA International can be there every step of the way for your product! From product development to helping with QMS upkeep and post-market monitoring, EMMA is here to bring your product full-circle. The expertise of the EMMA team can help you get through the biggest quality and regulatory hurdles in the life science industry with ease.
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Full Circle Consulting Resources
In May of 2022, the Center for Drug Evaluation and Research (CDER) at the Food and Drug administration (FDA) launched the Accelerating Rare Disease Cures (ARC) program. This program sought to bridge the complexities of rare disease drug development with the pressing needs of patients. With this program’s initiation, the Rare Diseases Team was formed within CDER to work and maintain collaborative relationships between internal and external rare disease stakeholders and scientific experts.
Every year the FDA compiles its Fiscal Year Report on the State of Pharmaceutical Quality. This report takes a look back at the previous fiscal year and identifies trends throughout CDER and the Office of Pharmaceutical Quality (OPQ) various surveillance activities to assess the state of pharmaceutical quality. Fiscal year 2022’s report card was published last month and provides a great insight into how pharmaceutical manufacturers are navigating a new post-COVID regulatory landscape.
Quality function deployment looks past the usual customer response and attempts to define the requirements in a set of basic needs, which are compared to all competitive information. All competitors are evaluated equally from customer and technical perspectives. This information can then be prioritized using a Pareto diagram. Management can then place resources where they will be the most beneficial in improving quality. Also, QFD takes the experience and information that are available within an organization and puts them together as a structured format that is easy to assimilate. This is important when an organization employee leaves a particular project, and a new employee is hired.
In April of this year, the FDA published two proposed regulations that, if finalized, would put limits on how much EtO can be used to sterilize products among other workplace/occupational hazard requirements. EtO, or ethylene oxide, is commonly used in the medical device industry to sterilize finished devices. Some examples of devices that are sterilized with EtO include gowns/drapes, heart valves, pacemakers, surgical drills, and catheters among many others.
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