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

This eLearning revisits the core purpose of SOPs, which is so often forgotten in many companies.  It will provide useful guidance on how to write, implement and maintain your SOPs within your Sites’ documentation hierarchy. Read more

This self-paced learning course provides comprehensive instruction on Sterile Manufacturing Practices in pharmaceutical manufacturing.   This course utilizes real-world scenarios, embedded video and audio content to instruct on the practical application of these requirements. Engaging knowledge checks are provided throughout each module, and the course concludes with a final competency assessment. The program is presented in three modules: - approximate course completion time = *4.5 hours. Once you finish the first module, you will automatically be able to begin the next module.   Module 1 - Introductory Topics – approximately 1.5 hour Provides key information relevant to microorganisms and sources of contamination, particularly in manufacturing areas.  At the end of this module, you will be able to: Explain the basics of microbiology Recognize what constitutes a sterile versus non-sterile product Define Aseptic environment Identify how specific organisms can cause contamination Recognize how Mother Nature is a potential contamination source Identify other potential sources in a manufacturing area   Module 2 - Intermediate Topics – approximately 2 hours Provides common terminology used in sterile manufacturing procedures such as: Clean Room, Unidirectional air, First air, Restricted access barriers (RABS) versus isolators, autoclave cycle, and isolators.  At the end of this module, you will be able to explain: HVAC Requirements Clean Room requirements and clean room preparation Personnel and material flow Primary packing components Sterilization with both heat and radiation Depyrogneation Steam in place (SIP) Terminal Sterilization Sterile Filtration   Module 3 - Advanced Topics – approximately 2 hours Provides information related to the practical application of Sterile Manufacturing Practices.  At the end of this program, you will be able to: Describe routes of administration and associated patients Successfully complete the gowning process Explain the interrelation between materials, people, equipment and environment for aseptic processing Be aware of the critical controls in place Identify specialized filling technologies Providing an overview of lyophilization Explain container-closure integrity (CCI) Perform visual inspection Explain clean room monitoring *Completion times included are approximate and based on the amount of content included in each section. Content is self-paced, driven by the learner. Read more