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As industry has been looking to reduce costs, improve efficiency, the FDA has begun to more closely scrutinize the industry effort to make certain that the above mentioned controls are in place. In this effort the FDA is focusing on supplier control and sampling issues.
The benefits of systematic reduced testing program include increased compliance, smaller inventory cycles, less testing, less handling, and increased productivity and efficiency.
Reduced testing test permits a medical product manufacturer to reduce testing of incoming components provided there are adequate controls on specification control, material qualification, supplier qualification & monitoring, material validation, and collaborative testing. Industry practice in the performance of reduced testing has resulted in new and modified expectations and requirements.
Why should you attend :
• To reduce costs and increase efficiency in the handling of incoming materials and components.
• To gain knowledge applicable to the control and qualification of suppliers that will increase compliance and improve efficiency
• To understand the compliance and quality requirements for reducing incoming material testing on pharmaceutical and medical device components.
Areas Covered in the Session:
• Advantages and disadvantages of reduced testing
• Basic review of quality systems.
• Brief review of regulatory requirements.
• Differences between suppliers and contractors.
• Interdepartmental roles in establishing and maintaining a reduced testing program.
• A study of the reduced testing lifecycle in graphical format , including specification control, material qualification, researching and selecting suppliers, supplier auditing (including selection of audit team members) and qualification, corrective actions, handling certificates of analysis, maintaining supplier quality and control, supplier change control, and handling problems suppliers.
• Logistics of implementing a reduced testing plan
Who will benefit:
• Quality Control
• Laboratory Manager
• Warehousing Purchasing Managers
• Procurement Managers
• Laboratory Analyst
• Cost Accounting
About the speaker:
Howard enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. One of his favorite areas is material and supplier control from which he receives great satisfaction in applying his knowledge for improvement.Ã‚Â