This course will cover the requirements in 21 CFR 121: Mitigation Strategies against intentional adulteration. It is more commonly known as the ‘food defense plan’ regulation. This course will provide an overview and introduction to food defense. You will learn the required components of a food defense plan and the basics of performing a vulnerability assessment. You will also learn about the FDA’s view of intentional adulteration in the dietary supplement industry under FSMA. This course will also provide references and ideas for implementing food defense plans and links to FDA resources for food defense plans. Read more

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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

This course is part of maintaining required compliance to 21 CFR 111 and provides opportunities for ongoing GMP training. Combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, participants in this course will: Take part in a collaborative online training developed to streamline the MMR development processes, focusing on: The difference between an MMR and a BPR The regulatory requirements for MMRs for dietary supplements FDA requirements for BPRs Gain specific guidance to help manage and avoid common issues and pitfalls with MMRs and BPRs. Learn best practices to simplify and improve your internal operations - enabling your batch records to withstand audits and inspections. Full Training agenda: • The regulatory requirements for MMRs for dietary supplements • The difference between an MMR and a BPR • FDA requirements for BPRs • Citations from recent Warning Letters • Creation and use of the Batch Production Record • Examples of best (and less-than-best) practices • Tips to improve your company’s MMRs and BPRs   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 of our 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.  Full details of each course are available via the links below: Analysis and Testing - 6 hours General Drug or Pharmaceutical cGMP and Quality Systems - 5 hours Process Validation and Equipment Qualification - 5 hours Pharmaceutical Microbiology - 5 hours Sterile Manufacturing Practices - 6 hours Each course contains engaging knowledge checks, and concludes with a final competency assessment and course completion certificate. 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