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

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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

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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

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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

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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 

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Crystallization: Mastering Seeded Antisolvent Techniques

Crystallization plays a pivotal role in the production of high-quality specialty bulk products. This process will influence particle size, purity, and product yield all while needing to be monitored and controlled to meet a product’s specifications. This fully accredited training is tailored for process chemists, chemical engineers, and pharmaceutical engineers. It delves into the critical… Continue reading Crystallization: Mastering Seeded Antisolvent Techniques

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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

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Precision Tools for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment, many variables that affect human behavior CAN be managed,… Continue reading Precision Tools for Human Error Reduction

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Surfactants: Chemistry, Theory,and Application

The high surface tension of water presents challenges to a formulator who attempts to develop products that will properly wet surfaces, disperse pigments, emulsify key components, or even generate or destabilize foam. This accredited course on surfactants (chemistry, theory, mechanism, and application) initially reviews the various types and chemical structures of commercially available surfactants. An… Continue reading Surfactants: Chemistry, Theory,and Application

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Rheology: Chemistry, Theory, and Application

We must understand how materials are affected, by their flow behavior, as a result of applied stress forces. This knowledge will allow a formulator to develop products with the best possible outcome considering production, storage, packaging, and application. This intensive, accredited training course on rheology (chemistry, theory, mechanism, and application) reviews the basic principles of… Continue reading Rheology: Chemistry, Theory, and Application

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