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

This self-paced learning course provides comprehensive instruction on the Process Validation and Equipment Qualification in pharmaceutical manufacturing. The program is presented in three modules: - approximate course completion time = *4.5 hours. Once you finish the first module, you will automatically begin the next module within this course. Completing the three modules will provide learners with a holistic view of validation encompassing pre-validation studies, process development, and process evaluation, emphasizing modern approaches that apply principles of QbD, PAT, and ongoing quality risk management (QRM).   Module 1 - Introductory Topics – approximately 1 hour At the end of this module, you will be able to: Explain the differences between active pharmaceutical ingredients, a bulk drug substance, and drug product Explain the r purpose of equipment qualification and process validation Describe how performance supports product quality by reducing variability    Module 2 - Intermediate Topics – approximately 1.5 hours At the end of this module, you will: Understand WHY, WHAT, and HOW to perform validation Learn the stages of process validation Understand the importance of change control in the context of pharmaceutical quality systems Recognize the important of building in  system safeguards – engineered or procedural   Module 3 - Advanced Topics – approximately 2 hours At the end of this module, you will be able to: Discuss Modern Process Validation and Guidance (FDA and ICH) Understand the importance of pre-validation studies to develop process knowledge Outline the importance of Quality Risk Management and how it applies to process validation (ICH Q09) Identify the importance of validation design and how to reduce variability   Outline a framework for reducing potential product quality and patient risks during commercial manufacturing and throughout the product lifecycle   *The course is self-paced so completion times are approximate, based on the amount of content in each section. Read more

Register for this online course to immediately gain free access to our QP information pack and gap analysis tool, as well as a number of other resources and short videos providing information on: How NSF provide QP training QP Eligibility Application Process Postgraduate qualifications with the University of Strathclyde….. and much more The online course outlines what you can expect as you train as a QP with NSF.  NSF trained QPs are widely regarded as the best in the industry.  We understand that making the decision to train as a QP is not an easy one to make.  It requires time, commitment, and cost and so we also host quarterly Q&A sessions with Catherine Kay, Executive Director, and Claire Bettany, QP Coordinator, to demystify the QP training process so that you can feel comfortable embarking on your path to qualifying as a QP.  You can register for your Q&A session of choice through the online course, which is hosted on our Learning Management System. NSF offers pharmaceutical Qualified Person training in conjunction with the University of Strathclyde in Scotland, one of the premier universities for pharmaceutical education in the UK. This blend of academic excellence and sound industry-based experience sets our QP training apart from the other providers and ensures an unparalleled success rate. We offer those taking pharmaceutical Qualified Person training the opportunity to gain a Master of Science (MSc) qualification, a postgraduate diploma (PGDip) or a postgraduate certificate (PGCert) in pharmaceutical quality and Good Manufacturing Practice (GMP). Read more

Why do you conduct Self-Inspections and why are they important to your organisation? This E-Learning session provides an overview of the key elements in each stage of the Self-Inspection process, outlining where it fits into the overall audit pyramid. At the end of the session, you will complete a short assessment to test your knowledge.  Following successful completion, you will be issued with a certificate.  Read more