Chemistry 101 for Medical Device Regulatory & Quality Professionals: Essential knowledge needed to Manage Drug&Device Combination Product Project 2017

Topics

• Molecular structure and its impact on drug activity (smaller molecules behave differently from larger molecules)
• Chemistry 101: A review of the basics
• CMC Regulatory Compliance: Brief but comprehensive review of the essetials
• Techniques commonly used in drug synthesis, manufacturing and quality control testing
• Case studies that illustrate common issues that arise relating to drug components in combination device products
• How to spot a CMC-related problem and what to do when you suspect one
• FAQs and Essential follow-up reading for those who want more resources

Who should Attend

• Quality Assurance professionals
• Regulatory Affairs professionals
• Scientific and Engineering / Product Development Managers
• Marketing professionals
• Consultants to any regulated industry