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

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

This course provides a basic understanding of cleaning and sanitation for dietary supplement facilities. Participants will learn the importance of sanitary facility design, how to build contamination prevention mitigation into the construction of the plant, and how to write a compliant environmental monitoring plan. You will learn what SOPs are required for general facility cleaning and sanitation. At the conclusion of this training, participants will have an understanding of what is required in order to have a compliant cleaning and sanitizing program. At the conclusion of this training participants will have an understanding of what is required in order to have a compliant cleaning and sanitizing program: • Discuss relevant terminologies • Review Personnel hygiene and training requirements • Discuss Facility cleaning and sanitizing • Latest advice from the CDC and WHO • Contamination prevention mitigation • Environmental monitoring • Development of Cleaning & Sanitizing Methods Please note there are two recordings for this session. Instructor: Norm Howe A PDF of the presentation will not be not be distributed for this recording. 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