This webinar will cover the current FDA requirement for raw materials used in producing APIs and drug products. Attendees will learn how to ensure that raw materials are of acceptable identity, quality and purity before use. This webinar will also provide best practices for avoiding FDA warning letters and 483 observations.
Why Should You Attend:
During the last several years, FDA has issued numerous observations and warning letters to pharmaceutical and biotechnology companies for lack of adequate systems for evaluating the suppliers of raw materials and the components, to ensure that these materials are acceptable for use. It is the FDA requirement that all raw materials that are received and used in producing APIs and drug products should be qualified using a system to ensure that raw materials are of acceptable identity, quality and purity before use.Areas Covered in the Webinar:
- Establish appropriate specifications for these materials and assure that your suppliers provide materials meeting these specifications.
- Have the quality unit approve these specifications.
- Ensure that raw materials received are suitable and approved by the quality unit prior to use.
- Set a vendor qualification program that provides adequate evidence that the manufacturer can consistently provide reliable and safe materials.
- Audit, monitor and regularly scrutinize the suppliers to assure ongoing reliability.
- Review FDA 483s and warning letters related to this topic.
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 Personnel
- Quality Assurance Personnel
- Production Staff
- Engineering Staff
- All personnel involved in an U.S. FDA-regulated environment
Course Provider
Jamie Jamshidi,
