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.
Full Service
Full Circle Consulting
When
Product Development
Regulatory Submissions
Post Market Compliance
Manufacturing and Distribution
Why
Regulatory Strategy
Quality System Development
Quality System Implementation
EMMA OnDemand
Featured Services
COVID-19
EU MDR and IVDR
MDSAP
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Full Circle Consulting Resources
Supply chain issues are occurring all around the country which includes drug shortages. Drug shortages are considered a public health threat as they can delay and deny critically needed care for patients. The Food and Drug Administration (FDA) has pushed for fewer drug shortages and short lead times for the past decade.
The Food and Drug Administration (FDA) is composed of six major centers. Each of these six centers are specialists in unique categories that fall under the FDA umbrella for regulations and each function autonomously.
ISO 9001 is the international standard that specifies requirements for a quality management system (QMS) and is used to ensure that products and services meet quality and customer requirements. It is the most practiced standard in the ISO 9000 series. The first version of ISO 9001 was published in 1987 by the International Organization for Standardization with the most current version being released in September 2015.
“Perceptions are shaped by past experiences, culture, attitude, values, upbringing, and more. Once you have formed this perception, it might be difficult for you to change your mind about your coworker even if he performs well”. This quote provides a great example of why it is so important for managers to study human perception. We all have internal biases. When we transition into the corporate world, we bring those biases with us. Additionally, stereotypes, selective attention, halo effect primacy effect, recency effect, contrast effect, projecting and self-fulfilling prophecy are just some examples of common perceptual distortions that if a manager is not aware of with their employees can have negative effects on both the work environment, as well as the productivity and profitability of a company.
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