This module provides a systematic approach to selecting, evaluating, and qualifying suppliers and contractors. It covers the complete supplier lifecycle from initial need identification through ongoing relationship management. The module emphasizes that supplier selection goes far beyond choosing the lowest-cost option, focusing instead on total cost of ownership, long-term partnership success, and comprehensive risk assessment.  Read more

This module emphasizes the critical role of documentation in Supplier Quality Management to ensure compliance, mitigate risks, and maintain supply chain quality. It explores verification methods, supplier file management, and the benefits of scalable, integrated systems. Read more

This module provides essential knowledge and practical guidance on implementing quality risk management (QRM) principles within supplier quality management systems. Explored are the regulatory requirements and practical application of risk-based approaches to managing third-party suppliers, materials, and services. Read more

This module equips quality and procurement professionals with practical strategies for establishing and sustaining effective supplier relationships that foster business success. In today's interconnected supply chain environment, your suppliers are extensions of your organization, making relationship management a critical competency for ensuring product quality, delivery performance, and customer satisfaction. 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