Regulatory courses by Cobblestone for the Pharmaceutical and Medical Device Industries
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
Read MoreFormulate 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
Read MorePersonal Care and Cosmetics Law 101
The cosmetics and personal care market is one of the fastest growing consumer markets in the United States, with the average U.S. consumer using upwards of a dozen beauty, health, and wellness products every day. Yet for many years, the barriers to entry in the cosmetics and personal care market have remained relatively low and… Continue reading Personal Care and Cosmetics Law 101
Read MoreRachel Raphael
Rachel Raphael is a Partner at Morgan, Lewis & Bockius LLP who serves as trusted counsel to consumer products, personal care, and cosmetics clients on a range of legal and regulatory issues with a particular focus on consumer protection and product safety. Rachel defends clients against claims of unfair and deceptive business practices, fraud, negligence,… Continue reading Rachel Raphael
Read MoreSabrina Ippolito
Sabrina Ippolito, is an accomplished expert in quality systems with over 15 years of experience in the industry. She holds a Bachelor’s degree in Biochemistry and is currently working towards completing her Master’s degree of Education in Adult Education, in addition, she is a member of the professional order of Chemists of Quebec (OCQ). Throughout… Continue reading Sabrina Ippolito
Read MoreMastering Quality Management Systems (QMS)
A Quality Management System (QMS) guarantees that products or services consistently fulfill or surpass customer expectations. Emphasizing quality enables organizations to boost customer satisfaction and loyalty, resulting in repeat business and positive feedback. In this fully accredited course, we’ll discuss how implementing a QMS involves several fundamental steps to ensure its effectiveness and success. Each… Continue reading Mastering Quality Management Systems (QMS)
Read MoreSupervising 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
Read MoreIn-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
Read MoreGMP 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
Read MoreCosmetic 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
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