Regulatory Compliance is the level of activity that provides assurance to the sponsor and the regulatory agency that all phases of drug development are conducted in compliance to the good practice regulations as mandated by the Federal Food, Drug, and Cosmetic (FD&C) Act. In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations for biologics and drug development. You will also examine how a pharmaceutical or biotechnology company can use the graded approach when following the good manufacturing practice (GMP) regulations for manufacturing, testing and control of clinical supplies and commercial products.
Course Content
Day 1Time 11:00 AM - 05:00 PM EDTFDA and its Statutory and Regulatory Requirements
Who Should Attend
This course will benefit professionals involved in working with pharmaceutical and Biotech products and management involved in drug development and FDA Regulatory Compliance:
- QA/QC analytical chemists
- QA/QC directors, managers
- Investigators in QA/QC
- Manufacturing/Production
- Research and Development
- Project management
- Manufacturing personnel
- CROs analysts
- Technical liaison
- Regulatory affairs personnel
- CMC specialists
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Quality auditors
- Document control specialists
- New hires, as well as Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance.