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This course provides an overview of the US and EU regulatory framework relative to combination products.  This course will discuss the primary mode of action (PMOA), key stakeholders, and Drug-Device Combination (DDC) product requirements as well as a brief discussion of the regulatory framework for jurisdictions beyond the US and EU. This course is approximately 1.5 hours in length and includes knowledge checks after each topic and a competency assessment.    Read More

Course 1 of our Data Integrity Series Problems with data integrity continue to lead to vigorous regulatory actions. Such issues can be prevented with a thorough knowledge and understanding of the regulators’ requirements.  This eLearning course is aimed at anyone working in the Pharmaceutical Industry and is designed to provide an overview of what is meant by data integrity, what needs to be considered during documentation completion, review and approval and how to keep your data complete, consistent and accurate throughout the data lifecycle. This course is course 1 of our Data Integrity series.   Read More

Course 2 of our Data Integrity Series This course will build on the key messages of course 1 and go beyond the basics.  It will look at some more specialised or particular aspects of this topic which has such a wide-ranging impact.  This course consolidates the knowledge and experience from 11 years of work as an ex MHRA Inspector.  Management and the Quality Unit need to have a deeper understanding of Data Integrity to give them the confidence to get involved and this module is designed to highlight the known weaknesses in company systems.   This course is course 2 of our Data Integrity series of courses.  We would suggest that prior to this course you take the free Data Integrity Introduction course, followed by the Data Integrity: Overview and Documentation Completion, Review and Approval course (course 1).   Read More

Course 3 of our Data Integrity Series Data Integrity Course 1, Basics of Data Integrity addressed what everyone needs to know for this essential topic.  Course 2 went beyond the basics focusing on the technical details for subjects such as auditing and computer systems management. In this third course we build on your essential knowledge to understand what the Senior Management should ensure is in place, in use and effective. Read More

The FDA is aware of some confusion surrounding the guidance, Deciding When to Submit a New 510(k) for a Change to an Existing Device. As such, FDA has worked diligently over the past few years to enhance predictability, consistency and transparency while maintaining a “least burdensome approach.” The new updated guidance provides greater detail of the regulatory framework, policies and practices underlying FDA’s decision-making process and provides much needed clarity for industry on FDA’s expectations. In this course we walk through these changes and discuss how to determine when to submit. Read More

In addition to providing an in-depth discussion of contemporary design and development principles and practices (and corresponding EU and FDA regulatory requirements), this approximately four-hour, self-paced course explores the essential relationships between risk management and design and development throughout the lifecycle of a medical device.  Read More

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