Intermediate

Development, Validation, and Application for Analytical Methods

This accredited course offers a streamlined overview of analytical method validation, focusing on key regulatory requirements set by ICH, USP, and FDA. Participants will gain practical knowledge of essential validation elements, including accuracy, precision, specificity, linearity, range, robustness, LOD/LOQ, and system suitability. The course covers method development processes, from test selection and experimental design to… Continue reading Development, Validation, and Application for Analytical Methods

Regulatory Guidance and Requirements for Analytical Methods Validation

One of the most crucial aspects of developing and marketing pharmaceutical drug substances and products is ensuring that the analytical methods used for testing provide accurate and reliable data. This data is essential for making informed business decisions and meeting regulatory requirements. Recognizing the significance of robust analytical methods, regulatory agencies such as the FDA,… Continue reading Regulatory Guidance and Requirements for Analytical Methods Validation

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

Effective Pharmaceutical Product Complaints Handling, Investigations & CAPA

This will equip you with an overview of the rules and regulations governing complaint handling and documentation within the pharmaceutical and related industries. In compliance with 21 CFR Parts 210 and 211, manufacturers are required to maintain a complaint log or register, establish a complaint handling and CAPA (Corrective and Preventive Action) system, and implement… Continue reading Effective Pharmaceutical Product Complaints Handling, Investigations & CAPA

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? 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

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