Subject: Compliance

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

James 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

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

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

Modernization of Cosmetics Regulation Act (MoCRA) Readiness

The FDA has expanded their authority with the Modernization of Cosmetics Regulations Act (MoCRA) to regulate the cosmetics industry. This regulation requires cosmetic product manufacturers to adhere to specific requirements at key deadlines to ensure the safety of cosmetics products that are used by consumers daily. This accredited training course will provide participants with an… Continue reading Modernization of Cosmetics Regulation Act (MoCRA) Readiness

Formulate Products Backed by Successful Clinical Testing Results

What comes first? The product or the claim. Learn how to develop personal care and cosmetic products and award-winning formulas with great claims in the proper order for success. The rules and regulations regarding supporting advertising claims for cosmetics have not changed. What we need to focus on is how to create unique products built… Continue reading Formulate Products Backed by Successful Clinical Testing Results

Personal Care and Cosmetics Law 101

The cosmetics and personal care market is one of the fastest growing consumer markets in the United States, with the average U.S. consumer using upwards of a dozen beauty, health, and wellness products every day. Yet for many years, the barriers to entry in the cosmetics and personal care market have remained relatively low and… Continue reading Personal Care and Cosmetics Law 101