This webinar first highlight the regulatory requirements of the quality system as found in both the US FDA regulations and those found in the Health Canada GMPs. The webinar will also examine the differences between Quality Assurance and Quality Control and the responsibilities of each. Quality System topics to be covered in addition to the regulatory requirements include personnel training, data integrity and quality expectations for laboratories, handling of deviations and OOS results, maintenance of an effective quality system through the establishment of CAPA and change control procedures and the importance of routine internal audits and audits of critical suppliers. Finally, the webinar will focus on the need to establish and adhere to procedures that address all of the topics listed above.

It is no surprise to anyone who reviews regulatory citations to notice the number of deficiencies cited that are associated with quality systems. Today, the basis for all FDA audits both within the US and internationally is based on the quality systems approach and the six systems that comprise it. Whether the audit is a full or partial audit, the quality system within a company will always be inspected. This webinar will define the basic items that an effective quality system should demonstrate. As a basis for regulatory audits, the quality system, its procedures and their implementation are reviewed to help verify the level of effectiveness in assuring consistent control and quality of materials, components and final product.