Why Should You Attend:
Good Manufacturing Practice regulations, which have the force of law, require that manufacturers, processors, and packagers of medicinal products take proactive steps to ensure that their products are safe, pure, and effective. cGMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.Personnel involved in cGMP must have documented training of current Good Manufacturing Practices (cGMP) training. This webinar will focus on the FDC Act and 21CFR federal regulations as applied to cGMP and provide an overview of the US FDA regulations for compliance.
Agenda
- What is cGMP and why is it important; Brief history of drug manufacturing
- Describe the federal regulations applied to cGMP and inspections
- Discuss: Organization and Personnel, Building and Facilities, Equipment, Production and Process control, Laboratory, Quality, Documentation
- Review listing of guidelines as apply to cGMP
- Terms and Definitions
