Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel

Overview: This webinar will address these complexities and break them down into their simple elements. Then these elements will be rebuilt into a practical system that will enhance understanding of the requirements.

This understanding of the requirements will provide you with the tools you need for developing or revamping your quality system to meet this new paradigm. This will result in a smoother development and approval for your product as well as prevent any "big showstoppers" that delay or threaten your project.

Why Should You Attend: As you know, medical diagnosis, technology, and treatment is very dynamic and is rapidly advancing. New discoveries are made that do not fit the "regulatory mold“and thus require new approaches to regulation. Combination products is one such area that has grown proportionally as technology advances creating in the need to rethink the processes for classification, design, quality assurance, and regulatory approval of such products. This challenges industry and the FDA to develop strategies for effectively working together to meet user and customer needs. As a professional, you are aware of the complexities of also combining the regulatory, business, and quality processes to make such products a reality.

Agenda

• Defining Combination Products and primary mode of action (PMOA)
• The Role of the Quality System, Regulatory Loop & and the Quality Manual
• Management Leads To Establish the Quality System and Develop a Competent Workforce
• The Teams and Interdepartmental Communications
• Management of the Documentation and Records
• Design Control & Risk
• Facilities and Equipment Design and Qualification
• Material Specification Development and Qualification
• Qualification and Control of Suppliers & Contractors
• The Master Records-Key to Process Control
• Establish the Process Control Then Validate & Control It
• Establish the Process and Validate, Then Continuous Monitoring
• Packaging & Labeling
• Distribution and Returns
• Problem Solving, Investigating and CAPA
• The Preapproval Inspection
• Preparing for the Submission Process
• Post Approval Monitoring: Establish the Process Control Then Control It
• Problem Solving-Nonconforming, Investigations, and CAPA systems

Who will benefit:

• Quality, quality control, regulatory, engineering, and manufacturing and IT staff working in the FDA regulated industry in the development and manufacture of medical products.
• Interdepartmental functions associated with scaling up and commercializing a new medical product
• Suppliers and software vendors, servicing the FDA regulated industry, who want to better understand the customer’s needs and requirements.