The research, development, manufacturing, and regulatory approval of new biotechnology and biopharmaceutical products often presents novel challenges for which a background in conventional pharmaceuticals offers little guidance.
To bridge this gap between academic instruction and the real-world complexities of research, development, validation, regulations, processing, and manufacturing, we provide practical, specialized training by industry experts. With ever-changing scientific understanding and government regulations, it’s critical that you have the most current information possible – training with COBBLESTONE ensures you will.
Laura Jeannel
Laura Jeannel is a Senior Quality Consultant for Farbridge Pharma Consulting, is an experienced Quality Assurance professional, leading as a former Quality Director and key consultant for over 20 years. During her career, she has led major pharmaceutical companies in establishing, executing, and continuous improvement for sustainable Quality Management Systems. Ms. Jeannel has been responsible… Continue reading Laura Jeannel
Read More21 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 MoreManagement of Pharmaceutical Water in a GMP Environment
Knowledge of the microbiology of water in a GMP environment is critical to the health of any water system being used to produce a pharmaceutical or biotechnology product. Even companies manufacturing tablets need to be aware of the quality of the water that may be contacting their process or product. The well-being of a facility… Continue reading Management of Pharmaceutical Water in a GMP Environment
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 More