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This course bundle provides comprehensive medical device regulatory requirements for all five countries currently utilizing MDSAP audits in their regulatory framework: Australia, Brazil, Canada, Japan and the United States. These five separate courses can also be purchased individually. Read more

This course is designed to provide an overview of US regulatory requirements for advertising and promotion of medical devices, with a focus on FDA as well as the corresponding standards, policies, procedures, and guidelines that apply to advertising and promotional activities. Upon completion of this course, learners will understand how advertising and promotion are defined, the required elements of advertising and promotional materials including on social media platforms, roles and responsibilities, and the regulatory risks associated with advertising and promotional activities. Read more

Maintaining proper complaint files is an essential element of the medical device quality management system. This course examines the importance of a properly functioning complaint handling system and the relationship between complaints, service reports, U.S. medical device reporting and CAPA. It provides a side-by-side comparison of complaint handling requirements in the U.S. versus those in the ISO 13485:2016 standard. Note: Due to the video nature of this course, we recommend taking the course in Google Chrome for optimal performance.     Read more

This self-paced digital learning course provides comprehensive instruction on Pharmaceutical Microbiology in pharmaceutical manufacturing.   The program is presented in three modules: - approximate course completion time = *5 hours. Once you finish the first module, you will automatically begin the next module within this course.   Module 1 - Introductory Topics – approximately 1 hour At the end of this module, you will: Explain Microbiological problems in the context of pharmaceutical manufacturing, including how to identify problems Learn the meaning of Microorganisms in their significance Understand HOW microorganisms grow and WHY it matters   ​Module 2 - Intermediate Topics – approximately 2.5 hours      At the end of this module, you will be able to: Review how microorganisms are counted and explain the rapid microbiological methods Outline the Identification of Microorganisms and explain pharmaceutical water systems Review Pyrogens and pyrogen testing Understand microbiological evaluations of raw materials Understand microbiological contamination and spoilage Learn the principles of preservation in the pharmaceutical context Understand Antibiotics and how to assess antimicrobial activity Outline and understand the importance of good disinfection practices   Module 3 - Advanced Topics – approximately 1.5 hours      At the end of this module, you will be able to: Review sterilization principles and methods Explain bio validation of sterilization Describe sterility testing in the pharmaceutical environment Discover Microbiological validation of cleanrooms Review Microbiological Environmental monitoring methods Learn how to perform a microbiological risk assessment *The course is self-paced so completion times are approximate, based on the amount of content in each section. Read more

According to Annex XIII, Part B, of the EU IVDR, manufacturers must proactively collect and evaluate performance and relative scientific data from the use of a device which bears a CE mark and is placed on the market or put into service in the European Union (EU) with the aim of confirming the safety, performance and scientific validity throughout the expected lifetime of the device, of ensuring continued acceptability of the benefit-risk ratio and detecting emerging risks on the basis of objective evidence.   This course provides insight into the terms associated with PMPF, and requirements relative to the development of a PMPF plan, the analysis of PMPF findings, documenting a PMPF evaluation report, and the nexus between PMPF to performance evaluation and risk management.  This brief, fundamental course would benefit anyone planning, conducting, or managing post-market surveillance activities within an IVD manufacturer particularly those new to the industry. Read more

Post-market surveillance for manufacturers is covered in EU MDR Articles 83-86. Articles 87-89 cover post-market vigilance requirements. This course reviews the requirements set forth in these articles in detail, with expert advice provided throughout the course. Read more

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