Subject: GMP

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

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

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

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

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