Introductory

Revalidation and Compliance in Life Cycle Management for Analytical Methods Validation

This accredited course provides a comprehensive overview of essential principles and practices related to method validation in regulated environments. The course covers key topics including revalidation, method revisions, and compliance issues in method validation. You will explore FDA-mandated updates, changesin drug substance, product, method/site, and technology that require revalidation. Additionally, the course addresses common compliance… Continue reading Revalidation and Compliance in Life Cycle Management for Analytical Methods Validation

Process, Application, and Data Analysis for Analytical Method Validation

This accredited course provides a comprehensive overview of key practices and regulatory requirements for method validation in pharmaceutical development. Focusing on data documentation, reporting, and compliance with FDA and USP guidelines, this session explores the essentials of experimental documentation, IND/NDA reporting, method verification (USP <1226>), and method transfer (USP <1224>). You will engage in workshops… Continue reading Process, Application, and Data Analysis for Analytical Method Validation

Development, Validation, and Application for Analytical Methods

This accredited course offers a streamlined overview of analytical method validation, focusing on key regulatory requirements set by ICH, USP, and FDA. Participants will gain practical knowledge of essential validation elements, including accuracy, precision, specificity, linearity, range, robustness, LOD/LOQ, and system suitability. The course covers method development processes, from test selection and experimental design to… Continue reading Development, Validation, and Application for Analytical Methods

Regulatory Guidance and Requirements for Analytical Methods Validation

One of the most crucial aspects of developing and marketing pharmaceutical drug substances and products is ensuring that the analytical methods used for testing provide accurate and reliable data. This data is essential for making informed business decisions and meeting regulatory requirements. Recognizing the significance of robust analytical methods, regulatory agencies such as the FDA,… Continue reading Regulatory Guidance and Requirements for Analytical Methods Validation

Fired Process Heaters

This comprehensive accredited course offers an in-depth exploration of fired heaters, essential components in various industrial applications. Attendees will gain a solid foundation in the design, operation, and optimization of fired heaters, focusing on key areas such as combustion, heat transfer, fluid dynamics, and emissions management. The course begins with an overview of fired heater… Continue reading Fired Process Heaters

Aerosol Technology Basics

Aerosols are a unique product form, utilized in an array of industries, that require a thorough understanding of the technology before acceptable formulations can be developed for consumer use. While traditional aerosol products have been around for many years, recent developments in propellants, valve systems and packaging innovations have opened up opportunities for completely new… Continue reading Aerosol Technology Basics

Effective Pharmaceutical Product Complaints Handling, Investigations & CAPA

Our online course will equip you with an overview of the rules and regulations governing complaint handling and documentation within the pharmaceutical and related industries. In compliance with 21 CFR Parts 210 and 211, manufacturers are required to maintain a complaint log or register, establish a complaint handling and CAPA (Corrective and Preventive Action) system,… Continue reading Effective Pharmaceutical Product Complaints Handling, Investigations & CAPA

Introduction to Stability Operations for Drugs, Biologics, and Medical Devices

New to “stability”, or a key stakeholder in the stability process, or just want to firm up your stability knowledge? Our 3-part series on Stability Operations for Drugs, Biologics, and Medical Devices will give you a rock-solid base for establishing or expanding your stability operations knowledge. Depending on your level of understanding, you can enroll… Continue reading Introduction to Stability Operations for Drugs, Biologics, and Medical Devices

INCI: International Nomenclature of Cosmetic Ingredients

In 1973 The Cosmetic, Toiletry, Fragrance Association (CTFA, now called Personal Care Products Council [PCPC]) developed an industry voluntary process for assigning ingredient names that provides the consumer and medical field a common approach to understanding what is formulated in a personal care product. This process was accepted by the United States Food & Drug… Continue reading INCI: International Nomenclature of Cosmetic Ingredients

Modernization of Cosmetics Regulation Act (MoCRA) Readiness

The FDA has expanded their authority with the Modernization of Cosmetics Regulations Act (MoCRA) to regulate the cosmetics industry. This regulation requires cosmetic product manufacturers to adhere to specific requirements at key deadlines to ensure the safety of cosmetics products that are used by consumers daily. This accredited training course will provide participants with an… Continue reading Modernization of Cosmetics Regulation Act (MoCRA) Readiness