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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 provides 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. 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

This video-based training course provides a basic understanding of design controls for medical devices and IVDs. It covers how to comply with the U.S. FDA’s Quality System Regulation, the quality management system international standard ISO 13485:2016 and EU MDR. Learn from global quality systems expert Kim Trautman, a former U.S. FDA official. Read More

Course Description: This fully online 2-day training course on Design Controls that is highly interactive and includes case study exercises, competency assessment, and a Certificates of Completion. This training will provide an understanding of the risk management and design and development regulatory requirements relative to FDA’s 21 CFR 820, ISO 13485:2016 and EU regulations; as well as practical examples of to how to minimize inefficient executions and documentation practices. Benefit is gained through open dialogue and sharing of current design and development processes to highlight how misperceptions of regulatory requirements have led to less than optimal practices.  This course will provide knowledge to assist in all phases of design and development projects. Read More

Course Description: This fully online 2-day training course is designed to provide practical instruction for auditors undertaking internal and supplier audits for the upcoming European in vitro diagnostic regulations (EU IVDR).  It is anticipated that students will already have internal audit experience and ideally have certified auditor / lead auditor qualifications in QMS audits. Course will include 2-hour EU MDR and 2-hour IVDR eLearning modules to be completed as prerequisite work. The course will: Describe the Regulation for the auditors; Provide practical instruction for Planning audits; and Provide practical instruction for Conducting audits. This course comes with a 2-hour "EU MDR Overview" overview prerequiste module that must be completed prior to the start of the live instruction. Read More

Course Description: This fully online 3-day training course is designed to provide practical instruction for auditors undertaking internal and supplier audits for the upcoming European medical device regulations (EU MDR). It is anticipated that students will already have internal audit experience and ideally have certified auditor / lead auditor qualifications in QMS audits. The course will: Briefly describe the Regulation for the auditors Ensure an understanding of the framework of the regulation in order to recall quickly Briefly provide practical instruction for Planning audits Specifically addressing Design, Technical documentation, Manufacturing, Supply-chain, Economic operators, Post-market support including servicing / sales affiliates etc. Briefly provide practical instruction for Conducting audits Specifically Auditing technical documentation, design process, manufacturing processes, suppliers, QMS processes   This course comes with a 2-hour "EU MDR Overview" overview prerequiste module that must be completed prior to the start of the live instruction. Read More

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