Regulatory courses by Cobblestone for the Pharmaceutical and Medical Device Industries
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
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 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 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 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 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
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