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

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 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 provides an overview of the US and EU regulatory framework relative to combination products.  This course will discuss the primary mode of action (PMOA), key stakeholders, and Drug-Device Combination (DDC) product requirements as well as a brief discussion of the regulatory framework for jurisdictions beyond the US and EU. This course is approximately 1.5 hours in length and includes knowledge checks after each topic and a competency assessment.    Read more

The purpose of this course is to provide an overview of current good CSV practice along with some practical advice about how to achieve good outcomes in a cost-effective and resource-efficient way. Read more

Course 1 of our Data Integrity Series Problems with data integrity continue to lead to vigorous regulatory actions. Such issues can be prevented with a thorough knowledge and understanding of the regulators’ requirements.  This eLearning course is aimed at anyone working in the Pharmaceutical Industry and is designed to provide an overview of what is meant by data integrity, what needs to be considered during documentation completion, review and approval and how to keep your data complete, consistent and accurate throughout the data lifecycle. This course is course 1 of our Data Integrity series.   Read more