The purpose of this course is to provide an introduction to Pharmacovigilance and why it is required to monitor the detection, assessment and prevention of adverse events, adverse reactions and side effects of medicinal products post marketing. Read More

This self-paced learning course provides comprehensive instruction on Analysis and Testing 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 four modules: - approximate course completion time = *6.0 hours. Once you finish the first module, you will automatically be able to begin the next module.   Module 1 – Prerequisite Program – approximately .5 hour A prerequisite program that provides basic and fundamental requirements of the quality control laboratory.  At the end of this module, you will be able to: Understand the eight stages of the data lifecycle Explain the proper use of Laboratory Notebooks Understand the crucial role of Quality in the validation and analysis of product design Explain Quality Control’s place in the Manufacturing Lifecycle   Module 2 - Introductory Topics – approximately 1.5 hour Provides key information relevant to analysis and testing, particularly in the Quality Control laboratory.  At the end of this module, you will be able to: Introduction into Analysis and Testing Understand Analytical Chemistry and the Quality Control Laboratory Understand Analyst Fundamentals Equipment and Instruments Materials and Supplies Analytical Balances   Module 3 - Intermediate Topics – approximately 2 hours Provides a deeper dive into laboratory systems.  At the end of this module, you will be able to explain: Introduction into Laboratory Systems Who’s Who in the Zoo The Laboratory Systems Other Key Laboratory Systems   Module 4 - Advanced Topics – approximately 2 hours Provides information related to Stability and stability programs, method validation versus verification and conducting laboratory investigations.  At the end of this program, you will be able to: Introduction Stability and stability programs Method Validation and Verification Conducting a Laboratory Investigation *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

NSF is a trusted name in the global pharmaceutical sector.  For decades, our experts have worked with the leading and most dynamic companies to ensure that their processes and facilities remain compliant. The Certificate in Pharmaceutical Manufacturing program brings together five e-learning courses that meet the educational needs for a professional involved in the manufacture of medicines for the pharmaceutical sector. The courses can be taken individually or purchased at a specially priced bundle rate.  They are: Analysis and Testing  General Drug or Pharmaceutical cGMP and Quality Systems Programme Process Validation and Equipment Qualification Microbiology  Sterile Manufacturing  Each course contains engaging knowledge checks, and concludes with a final competency assessment and course completion certificate. Read More

This 45 minute self-paced learning course provides an overview of the requirements of a change control process. The change control system provides a systematic approach to managing all GxP changes made to a product or system. The review and approval of changes prior to their implementation allows us to ensure that no unnecessary changes are made and the proposal is risk assessed to determine if there will be an impact to product safety, quality, efficacy, ultimately to ensure that the patient is not harmed by any changes made. Read More

This course highlights the proposed and recently implemented changes to EU law and regulatory guidance that will impact the manufacture and distribution of medicinal products, across the product lifecycle, and will provide valuable insights for personnel, in quality, regulatory, management or technical support roles in the pharmaceutical industry.  It will help Qualified Persons to fulfil their legal obligation for continuing professional development (CPD). PLEASE NOTE: As well as being available to purchase individually these Pharmaceutical Legislation and Guidance eLearning updates are also available to purchase together as an annual subscription service.  The advantages of the subscription are as follows: All four courses (EU, UK, USA and International) are provided for less than the cost of 3 individual courses The full recordings, updated each quarter year, on the LMS are available on the LMS throughout the whole of the year of your subscription A shorter summary of what has changed in the past quarter, across all four regions, is provided with each quarterly update Each quarter you will be invited to a live, Zoom Q&A session 2 to 3 weeks after the publication of the quarterly update To enrol in the subscription service, click here. Read More

This course highlights the proposed and recently implemented changes to international regulatory guidance that will impact the manufacture and distribution of medicinal products, across the product lifecycle, and will provide valuable insights for personnel, in quality, regulatory, management or technical support roles in the pharmaceutical industry.  It will help Qualified Persons to fulfil their legal obligation for continuing professional development (CPD). PLEASE NOTE: As well as being available to purchase individually these Pharmaceutical Legislation and Guidance eLearning updates are also available to purchase together as an annual subscription service.  The advantages of the subscription are as follows: All four courses (EU, UK, USA and International) are provided for less than the cost of 3 individual courses The full recordings, updated each quarter year, on the LMS are available on the LMS throughout the whole of the year of your subscription A shorter summary of what has changed in the past quarter, across all four regions, is provided with each quarterly update Each quarter you will be invited to a live, Zoom Q&A session 2 to 3 weeks after the publication of the quarterly update To enrol in the subscription service, click here. Read More

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