This training course covers the GxP Inspection Management Lifecycle.  It is suitable for staff wanting to understand more about GCP, PV, GMP and GDP regulatory inspections from planning, conduct and responding to inspection findings.  Read more

This eLearning session provides an overview of the interface of GMP with GCP Quality Management Systems.  This course of four chapters will provide you with an understanding of the similarities and differences between GCP and GMP.  The chapters include short interactive quizzes to test your knowledge and following successful completion of the course, you will be issued with a certificate. (Note that course success and completion are based on finishing all of the content - not the quiz scores.) Read more

This introductory session (which is divided into 3 chapters) is ideal for staff in operational and support areas – production, engineering, QC, QA, validation and technical, as well as those new to the pharmaceutical industry and/or microbiology. We cover the real meaning of microbiology in operations and why it matters. You’ll learn the risks associated with microbes and how to eliminate or control them so that the patient is protected. You will be able to apply your knowledge from this session in your daily work. 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