Intermediate

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

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? This 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. This accredited course is part 2 of a 3-part series… Continue reading Intermediate Stability Operations for Drugs, Biologics, and Medical Devices

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

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

GMP Change Control Process

Change control is a requirement of all regulatory agencies and authorities worldwide. It is a critical GMP function that must be addressed daily. The value of identifying and tracking change is to prevent unintended consequences, remain in proper process alignment, and avoid any alteration of the products’ Safety, Identity, Strength, Purity, and Quality (SISPQ). Many… Continue reading GMP Change Control Process

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

Ethylene Oxide: Product Adoption and Parametric Release

Ethylene Oxide (ETO) Sterilization is a critical process for medical devices, which might include pharmaceuticals and the food industry. Today, the challenge is to understand product adoption during material changes to simplify and have a more robust product validation process based on product families. Another benefit is to have a better understanding on Parametric Release… Continue reading Ethylene Oxide: Product Adoption and Parametric Release

Developing and Optimizing of Roll Compacted Granulations for Tablets

Granulating is the most popular way to prepare materials for tableting. Many excipients and actives used in modern direct compression processes are granulated. The granulation process, using only pressure for particle size enlargement, is dry granulation (Roll compaction (RC)). The RC process, even though simple in principle, can be quite complex. Besides proper machine setup,… Continue reading Developing and Optimizing of Roll Compacted Granulations for Tablets

21 CFR 211 Subparts I: Laboratory Controls

Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality are the Current… Continue reading 21 CFR 211 Subparts I: Laboratory Controls