Regulatory 101 for Medical Device Start Ups

Establishing a Culture of Compliance

While having robust compliance policies and procedures in place is essential for meeting regulatory requirements, it's equally important to establish a culture of compliance within your organization. A culture of compliance means that every employee understands the importance of compliance and is committed to upholding it in all their work. Here are some tips for establishing a culture of compliance...

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...

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Katie McCallum

More Resources

Establishing a Culture of Compliance

Change Management And Control

Aseptic Technique and Gowning

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