Event Date/Time: Sep 30, 2008
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 seminar:
* Establish appropriate specifications for these materials and to assure your suppliers provide materials meeting these specifications.
* Have the specifications be approved by the quality unit.
* Ensure that raw materials received are suitable and approved by the quality unit prior to use.
* Set a vendor qualification program that provide adequate evidence that the manufacturer can consistently provide reliable and safe materials.
* Audit, monitored and regularly scrutinized the suppliers to assure ongoing reliability.
* We will also review FDA 483s and Warning Letters relating to this topics.
Who will benefit:
* Biotechnology industries