Subject: Compliance Courses by Cobblestone – FDA-regulated industries
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 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 MoreWriting Standard Operating Procedures (SOPs) for Human Error Reduction
Poorly written SOPs are responsible for over 40% of human error events in manufacturing and are the leading cause of regulatory citations. Well-crafted procedures are critical for both successful execution and regulatory compliance. Proper procedures need to be clear, user-friendly, and include all necessary information for regulators. However, many procedures are flawed, leading to decreased… Continue reading Writing Standard Operating Procedures (SOPs) for Human Error Reduction
Read MoreJames Vesper, PhD, MPH
James Vesper as worked in the pharma industry for more than 40 years, first at Eli Lilly and Company where his last assignment was starting and leading the global GMP Training group. Before joining ValSource in 2017, he was president of LearningPlus, a training consultancy. His areas of interest are learning, human performance, root cause… Continue reading James Vesper, PhD, MPH
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 MoreINCI: 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
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