Courses by Cobblestone on the subject of R&D
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
Read MoreProcess, 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
Read MoreDevelopment, 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
Read MoreRegulatory 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
Read MoreAhmad Farhad
Ahmad Farhad is a seasoned Consultant in the Biopharmaceutical industry, specializing in Analytical Chemistry, method development, and validation for cGMP and compliance. Previously, Mr. Farhad held the position of Director of Quality Control at Bachem Americas Inc. Prior to joining Bachem, he amassed over 20 years of experience in leading method development and validation roles… Continue reading Ahmad Farhad
Read MoreAerosol 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
Read MoreRamez Labib, PhD, MBA, DABT, ERT
Dr. Labib is an experienced leader, manager, scientist and teacher with more than 20 years in toxicology. Working primarily for Avon and Johnson & Johnson, he has led teams dedicated to regulatory compliance, risk assessment, and product safety in the consumer industry sector. He has recently joined Venebio Consulting to lead the toxicology program and… Continue reading Ramez Labib, PhD, MBA, DABT, ERT
Read MoreCosmetic Raw Material Safety Assessment
This 90-minute accredited course provides the special knowledge about toxicology and risk assessment within the cosmetic industry. Cosmetic regulations worldwide require every ingredient in cosmetic products to be safe for use on the human body in rinse-on or rinse-off products, such as face creams or shower gels. For example, the recently enacted Modernization of the… Continue reading Cosmetic Raw Material Safety Assessment
Read MoreAmeann DeJohn
Ameann is a multi-talented, creative, visionary leader, with more than 30 years in the beauty industry. Her successful record provides her the ability to see beyond the normal limits of conventional wisdom. Her gusto for generating dynamite solutions to business challenges has enabled her to assume positions in national and international companies. Ameann is widely… Continue reading Ameann DeJohn
Read MoreIntermediate 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 Intermediate Stability Operations for Drugs, Biologics, and Medical Devices
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