Regulatory courses by Cobblestone for the Pharmaceutical and Medical Device Industries
21 CFR 211 Subparts E & F: Control of Components and Production/Process Control
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 E & F: Control of Components and Production/Process Control
Read More21 CFR 211 Subparts G & H: Packaging, Labeling and Distribution
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 G & H: Packaging, Labeling and Distribution
Read More21 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
Read More21 CFR 211 Subparts J & K: Records and Salvaged Drug Product
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 J & K: Records and Salvaged Drug Product
Read MoreFDA Quality Systems Guideline
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 FDA Quality Systems Guideline
Read MorecGMP Compliance and Non-Compliance
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 cGMP Compliance and Non-Compliance
Read MorecGMP Compliance: Process Validation
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 cGMP Compliance: Process Validation
Read MoreAn Introduction to Current Good Tissue Practice (GTP)
The US FDA’s current Good Tissue Practice regulations constitute a significant compliance challenge for the Human Tissue Industry. This course is intended to provide hands-on training for anyone who works for human cell, tissue, and cellular and tissue-based products companies which must comply with CGTP. In this intensive training, we will review the Public Health… Continue reading An Introduction to Current Good Tissue Practice (GTP)
Read MoreINCI: International Nomenclature of Cosmetic Ingredients
In 1973 The Cosmetic, Toiletry, Fragrance Association (CTFA) developed an industry voluntary process for assigning ingredient names that provides the consumer and medical field a common approach to understanding what is formulated in a personal care product. This process was accepted by the United States Food & Drug Administration (FDA) and the global regulatory community,… Continue reading INCI: International Nomenclature of Cosmetic Ingredients
Read MoreIntroduction to Softgel Manufacturing and Controls
Softgel dosage forms represent a modern take on the traditional tablet product, the most common type of pharmaceutical products produced. In the patient’s hand, a softgel can seem like a simple product not knowing there are numerous complexities that go into its manufacture. But for the manufacturer, without a clear understanding of the science behind… Continue reading Introduction to Softgel Manufacturing and Controls
Read More