Subject: Regulatory

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 

Aerosol Technology 101

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 new opportunities for new… Continue reading Aerosol Technology 101

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

Cosmetic Products Development

This fully accredited course will provide a step-by-step guide to the cosmetic product development process, helping you understand technical marketing, formulation, and testing strategies necessary to obtain efficacious, high-quality products. An “ideation-to-product introduction” approach will be presented, with technical and marketing milestones needed to be met during each critical stage of product development. The topics… Continue reading Cosmetic Products Development

Precision Tools for 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 Error Reduction

Walter G. Chambliss, Ph.D.

Walter G. Chambliss, Ph.D., is Professor Emeritus of Pharmaceutics and Drug Delivery and Research Professor Emeritus at the Research Institute of Pharmaceutical Sciences at the University of Mississippi. He teaches graduate courses in pharmaceutical formulation development, manufacturing, and regulatory sciences. He also lectures in the Hands-on Course in Tablet Technology (tabcourse.com), a post-graduate education course.… Continue reading Walter G. Chambliss, Ph.D.

Introduction to Validation Principles, Practices and Requirements

FDA-regulated industries utilize several types of validation to help ensure the quality of their products and to comply with FDA and international regulations and requirements. This training course provides an overview and introduction to Validation principles and requirements. Process validation, Computer System Validation, Cleaning Validation, Methods Validation, Qualifications, and Validations Project Management are all topics discussed in… Continue reading Introduction to Validation Principles, Practices and Requirements

Good Manufacturing Practices (GMP) for Foods

This course is designed to provide participants with comprehensive knowledge and practical skills in developing an effective Food Safety Program. The course covers the essential elements of food safety, including good manufacturing practices, and Hazard Analysis and Critical Control Points (HACCP) programs, specifically tailored for food manufacturing facilities, and sanitary design. The course will explore the fundamental… Continue reading Good Manufacturing Practices (GMP) for Foods

21 CFR 211 Subparts A & B: Quality and Personnel

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 standards for ensuring pharmaceutical quality are the Current… Continue reading 21 CFR 211 Subparts A & B: Quality and Personnel