This webinar will discuss in detail all parts of the regulations set forth in part 210 and in parts 211 of 21 CFR chapters. Attendees will learn how to comply with these regulations.
Why Should You Attend:
21 CFR Parts 210-211 contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. In this presentation all parts of the regulations set forth in part 210 and in parts 211 of 21 CFR chapters will be reviewed and discussed in details.Areas Covered in the Webinar:
- What is CFR? The history and reason.
- How to apply and comply with 21 CFR Parts 210-211.
- Review most common CGMP deficiencies and FDA Observation.
- Help manufacturers meet requirements of the Agency’s current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211).
Who Will Benefit:
This training applies to personnel/companies primarily in the pharmaceutical, and biotechnology industries. The employees who will benefit include:- Senior management
- Regulatory Affairs
- Quality Assurance
- Production
- Engineering
- All personnel involved in a U.S. FDA-regulated environment
Course Provider
Jamie Jamshidi,