Good Manufacturing Practices (GMPs) courses by Cobblestone
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 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 MoreAdvanced 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 Advanced Stability Operations for Drugs, Biologics, and Medical Devices
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
Read MoreIntroduction 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
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
Read MoreKevin Linde
Kevin Linde is an Illinois Professional Engineer with over 27 years of extensive experience in the pharmaceutical and FDA regulated industries. He is the CEO of cGMP Consulting, a company specializing in serving FDA-regulated industries such as pharmaceuticals, medical devices, cosmetics, biotechnology, and dietary supplements, that offers a comprehensive range of services. Kevin has led… Continue reading Kevin Linde
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