Subject: Manufacturing

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

Danielle Reynolds

Danielle Reynolds is Managing Director and Founder of D.T. Reynolds Consulting LLC. The company offers a broad range of consulting services to the Pharmaceutical, Chemical, Biotechnology, Life Science support industry and Life Science Workforce Development. With more that 20 years’ experience in the Biologics operations and higher education, Danielle has a proven track record of… Continue reading Danielle Reynolds

GMP in a Nutshell: Introduction to Current Good Manufacturing Practices

The quality of pharmaceutical products is subject to a lot of scrutiny and meticulousness regarding quality because anything less than the best possible quality could result in financial losses and regulatory issues for companies. Good Manufacturing Practices (GMPs) is a set of guidelines used to ensure consistency in the manufacture of quality healthcare products. These… 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

Supervising a Human Error Free Environment 

Supervision plays a crucial role in Human Error Reduction and Control. In this fully accredited training, critical factors like preparation, planning, scheduling, communication, among many others, will be discussed. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of… Continue reading Supervising a Human Error Free Environment 

In-depth Look into Softgel Formulation, Manufacturing and Troubleshooting

Softgels are widely popular dose forms for liquid that represent the most important oral form for less than 5 milliliters of liquid. Additionally, softgels are vital as a lipid delivery system, enhancing both solubility and permeation of Active Pharmaceutical Ingredients (APIs) by targeting the lipid absorption route. Softgels may appear to be a simple, two-part… Continue reading In-depth Look into Softgel Formulation, Manufacturing and Troubleshooting