The research, development, manufacturing, and regulatory approval of new biotechnology and biopharmaceutical products often presents novel challenges for which a background in conventional pharmaceuticals offers little guidance.
To bridge this gap between academic instruction and the real-world complexities of research, development, validation, regulations, processing, and manufacturing, we provide practical, specialized training by industry experts. With ever-changing scientific understanding and government regulations, it’s critical that you have the most current information possible – training with COBBLESTONE ensures you will.
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 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 MoreEffective 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
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
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