The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: May 20, 2021 at 9am to May 21, 2021 at 5pm
Street: Compliance Online, 2479 E. Bayshore Road
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Event Type: seminae
Organized By: ComplianceOnline
Latest Activity: May 13
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 and this seminar will help review what are the expectations and the common areas to be familiar with. 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.
This training will examine the differences between Quality Assurance and Quality Control and the responsibilities of each. In addition, attendees will discuss what characteristics quality personnel should possess. The current expectations for an effective quality system program as defined in both the FDA and EU requirements and guidance documents will be reviewed. Topics to be covered will range from the development of a quality manual and procedures, the importance and scope of audits (internal, vendor, third party and regulatory) along with review of various case studies to help further illustrate points discussed.
The quality department within companies is responsible for nearly all activities to various degrees that have impact on the quality, safety or efficacy of the final product or material produced. It is also responsible for helping assure that contracted services, which is more common today than ever before, are also verified to meet the quality standards set both by the company and the regulatory requirements. The training will review special topics of interest to auditors such as CAPA programs and investigations that address deviations and out of specification (OOS) results. Attendees will be given ample opportunity to ask questions, discuss actual case studies and to learn about the vast scope of responsibility that the quality system regulations expect and the roles of their own positions..
Upon completing this course participants should:
This course is designed for people within the quality unit, those impacted by quality requirements, third party suppliers who are evaluated against quality issues and their adherence to them, along corporate management who is required to provide the time and resources to correct quality issues identified. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization's performance. Following personnel will benefit from the course: