Subject: Regulatory

Writing 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

Effective 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

Ramez 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

Cosmetic 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

Ameann 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

Advanced 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

Intermediate 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

Introduction 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

INCI: 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

Kevin 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