"Basic Components of Establishing Quality Agreements"
About This Event
DESCRIPTION
Why you should attend
This webinar will highlight the importance of quality agreements that are expected to be in place as part of a quality system program. As companies become more dependent on foreign suppliers for materials, components and services, the need to have defined specifications and responsibilities are critical to assuring consistent achievement of the respective release criteria. Recent problems with the quality assurance of APIs and control of supply chains have brought increased scrutiny by federal auditors. The webinar will provide a good template of what is expected and topics to be covered.
Description of the topic
With the ever expanding dependence on suppliers, many of which are located in Asia, the assurance of obtaining quality materials, components and APIs is increasingly dependent on defining expectations and responsibilities for both parties. The “supply chain” process must be controlled and verified by both audits, defined specifications and more importantly, how potential changes to these items need to be clearly documented, communicated and evaluated.
This webinar will provide the attendees with a general overview of current regulatory requirements for establishing quality audits, along with recommended topics to be included. These topics and the respective sections that cover them in 21 CFR include change and deviation management, complaint handling, and expectations for documentation and records. The webinar will also provide examples of recent FDA 483 observations as they relate to this topic. Attendees will have the chance to ask questions relating to their own quality agreements issues.
Areas Covered In the Seminar
• Review of regulatory references relating to quality agreements.
• Discuss topics to be included in such agreements and the respective responsibilities.
• Importance of quality audits in developing quality agreements.
• Enforcement of quality agreements.
Who will benefit
Regulatory
Manufacturing
Production
Quality Assurance
Vendors
Management
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance