Subject: Manufacturing

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

Aerosol Technology Basics

Aerosols are a unique product form, utilized in an array of industries, that require a thorough understanding of the technology before acceptable formulations can be developed for consumer use. While traditional aerosol products have been around for many years, recent developments in propellants, valve systems and packaging innovations have opened up opportunities for completely new… Continue reading Aerosol Technology Basics

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

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

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

Rachel Raphael

Rachel Raphael is a Partner at Morgan, Lewis & Bockius LLP who serves as trusted counsel to consumer products, personal care, and cosmetics clients on a range of legal and regulatory issues with a particular focus on consumer protection and product safety. Rachel defends clients against claims of unfair and deceptive business practices, fraud, negligence,… Continue reading Rachel Raphael

GMP in a Nutshell: Introduction to Current Good Manufacturing Practices

The quality of pharmaceutical products is subject to rigorous scrutiny and meticulous control because anything less than the best possible quality could result in regulatory issues. More importantly, compromised quality could jeopardize patient safety, leading to potentially serious health risks. Current Good Manufacturing Practices (cGMPs) are regulations (21CFR210-211) used to ensure consistency in the manufacture… Continue reading GMP in a Nutshell: Introduction to Current Good Manufacturing Practices

Equipment Qualification in the GxP Environment

Whether your operation is covered by GMP, GLP, or GCP, there is a regulatory requirement to ensure that all equipment used has been properly demonstrated and documented to be functioning properly. Commonly referred to as Installation Qualification, Operational Qualification, and Performance Qualification, IQ/OQ/PQ provides the framework under which this process can be appropriately performed. Overlooking… Continue reading Equipment Qualification in the GxP Environment