21 CFR 111 Suplemento dietético BPF - Español La FDA espera que todas las empresas que fabrican, empaquetan o almacenan productos de suplementos dietéticos sigan 21 CFR 111, las Buenas Prácticas Actuales de Fabricación de Suplementos Dietéticos (cGMP). Combinando una amplia experiencia en la industria y una comprensión concreta de las reglamentaciones con una formación flexible y conveniente, este curso proporciona una sólida comprensión de las cGMP y las responsabilidades que se esperan de varias personas y grupos dentro de la empresa. Aprenderá cómo aplicar los principios de cGMP a situaciones específicas. La capacitación 21 CFR 111 GMP es interactiva, con ejercicios prácticos que incluyen estudios de casos de cartas de advertencia recientes. Traiga sus preguntas y prepárese para interactuar con el instructor y sus compañeros en la industria. Este curso de capacitación de GMP de suplementos dietéticos proporciona una descripción general de las subpartes A-P de la regulación 21 CFR 111, que incluye: •Especificaciones • Registros maestros de fabricación/registros de producción por lotes • Autoridad de calidad y FDA • Cartas de advertencia • Cómo dar sentido a regulaciones complejas de una manera comprensible y completa • Cómo convertir de manera efectiva las regulaciones en ejemplos y escenarios del mundo real, ofreciendo claridad y éxito operativo • Cómo se pueden aplicar las reglamentaciones a su organización de manera rentable Please Note: Tenga en cuenta: una vez que haya completado su registro, tendrá acceso a la grabación durante 30 días. Un PDF de la presentación no estará disponible. Se emitirá un Certificado de participación una vez que se complete con éxito la evaluación del curso. Costo: $499.00 USD    Read More

Dietary supplement manufacturers may be exempt for the preventative controls requirements of 21 CFR 117, but they are not completely exempt from all aspects of this new regulation. In this one hour webinar we will highlight the aspects of 21 CFR 117 that apply to dietary supplement manufacturers and raw material suppliers. You will learn what new cGMP requirements found in subpart B of 21 CFR 117 are required for dietary supplement manufacturers and are now an extension of the cGMP requirements in 21 CFR 111. This webinar will help you learn how to determine which parts of 21 CFR 117 apply to dietary supplement manufacturers and to raw material suppliers. Instructor: Jennifer Alfrey A PDF of the presentation will not be not be distributed for this recording. You'll have access to the recording for 15 days once you complete your registration.  Certificate of participation are not issued for recorded courses​. Read More

Food defense is a new area of compliance for the food industry which includes dietary supplement manufacturers. In this one-hour course we will cover the aspects of 21 CFR 121 that apply to dietary supplement manufacturers and raw material suppliers. You will learn what a food defense plan is and what is meant by intentional adulteration. • Understand what a food defense plan is • Know where to find the new regulations • Understand how to perform a vulnerability assessment • Understand how intentional adulteration in the dietary supplement industry is covered under the food defense regulation • Know how this new regulation in 21 CFR 121 impacts Dietary Supplement Manufacturers and raw material suppliers.   Once you've completed your registration, you will have access to the recording for 15 days. Please note PDF's of the presentation will not be available. Certificate of participation are not issued for recorded courses​. Read More

21 CFR 111 Dietary Supplement CGMP Overview  This course provides an overview of 21 CFR 111, the Dietary Supplement CGMPs. This abridged course includes an introduction to current good manufacturing practices (cGMPs), required product quality elements, documentation, investigations and a brief overview of the relevant subparts. We will also review the proper way to execute GMP records, detail the personal hygiene requirements, examine the meaning of master and batch records for control of production, labeling and packaging, clarify the requirements of quality and, describe the purpose of GMP rules, regulations and FDA enforcement. o Personnel o Buildings and Facilities o Equipment o Facility Records o Production and Process Control o Holding and Distribution o Batch Records o Packaging and Labeling o Quality Control and Quality Assurance o Laboratory Operations o Product Complaints · The role of the FDA and their authority The roles and responsibilities of the Quality Unit As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis. Instructor: Shawn Ludlow Once you've completed your registration, you will have access to the recording for 15 days. Please note PDF's of the presentation will not be available. Certificate of participation are not issued for recorded courses. 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

Comprehensive regulatory requirements including the regulatory framework, pre- and post-market requirements, and instruction on the way Australia is utilizing MDSAP. Read More