Today, any new medical device that is found not substantially equivalent for a reason other than performance data not previously classified based on risk is "automatically" or "statutorily" classified as a Class III device. This occurs because, by definition, a new device type would not be equivalent to a device type on the market before the 1976 Medical Device Amendments were placed in force or that has since been classified as a Class I or Class II device. This can have many levels of implication to a manufacturer of a low-risk device that suddenly finds themselves in the position of having their device classified as a Class III.

Standard Operating Procedures and Work Instructions - the documentation required by regulation - is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement - as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc. The key is to knowing how to write those documents to properly meet those needs.

This training will help you understand what a combination product is, highlight some of the changes in how the FDA views combination products, the approval steps for combination products and proposed regulations for these types of products.

Legal marijuana is one of the fastest-growing industries in the U.S., with more and more states starting to legalize medical marijuana to varying levels of control and regulation. However, the federal government has not yet legalized medical cannabis (though this situation might soon change). As a result, the industry lacks a common framework/standard for food safety - compared to other industries like pharmaceuticals and food. In such a scenario, companies that produce and sell marijuana products have a huge challenge ahead of them: how do they ensure that their products are safe - and how do they maintain their consumers' trust. Leaders in the cannabis industry are leading the way out of this confusion and opting for high safety and Good Manufacturing Practices (GMPs) - and so should you.

This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.

Compliance documentation to include Standard Operating Procedures, the documentation required by regulation is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc. The key is to know how to write those documents to properly meet those needs.

Project management is often called the accidental profession because there is no professional path from specific university education to actual practice. It is rather, a body of skills that many managers assume that most people possess. That is simply not the case. Furthermore, the types of projects that this webinar addresses, projects addressed by internal work teams, are often led by those within the organization with the least experience to do so. This webinar will help that manager get started and placed on the right track.

This webinar will review the Medical Device Classification Procedures which includes the De Novo process in conjunction with the recent changes to 21 CFR 860 that pertain to the reclassification of the post amendment devices and the De Novo process in general.

Legal marijuana is one of the fastest-growing industries in the U.S, with more and more states starting to legalize medical marijuana to varying levels of control and regulation. However, the federal government has not yet legalized medical cannabis (though this situation might soon change). As a result, the industry lacks a common framework/standard for food safety - compared to other industries like pharmaceuticals and food. In such a scenario, companies that produce and sell marijuana products have a huge challenge ahead of them: how do they ensure that their products are safe - and how do they maintain their consumers' trust. Leaders in the cannabis industry are leading the way out of this confusion and opting for high safety and Good Manufacturing Practices (GMPs) - and so should you.

This webinar will overview the important critical content of these two revised documents to include the most important checklists that are contained in the Refuse to Accept Policy guidance that provides acceptability criteria for each 510(k) - Traditional, Abbreviated, and Special.

This training will help you understand what a combination product is, highlight some of the changes in how the FDA views combination products, the approval steps for combination products and proposed regulations for these types of products.

This webinar will detail the medical device classification process for the United States through the FDA and will overview the very complex process for medical device classification within the EU. Specifically, this webinar will provide detailed background into the process and will make clear some of the very complex terms and sub-processes associated with medical device classification. We will actually work through the classification process step-by-step for the US and will overview how the process is accomplished for the EU.

This webinar will explain the best-in-class applications of training and how training can significantly contribute to not only world-class compliance but improved operational performance, improved quality, and improved employee/associate safety.