This webinar will discuss current regulatory and quality requirements for reduced testing of components used in pharmaceuticals and medical devices. Reduced testing will be viewed from current industry practice, the regulations, and quality principles. The reduced testing lifecycle will be studied and reviewed. This includes such topics as component specifications, material qualification, supplier auditing and qualification, collaborative laboratory testing, certificates of analysis, material validation sampling, analyzing testing, qualification, and disqualification. Examples of systems will be shown. This webinar will primarily use graphics, especially flowcharts, to demonstrate the principles and increase an understanding of the topics.
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.
The benefits of systematic reduced testing program include increased compliance, smaller inventory cycles, less testing, less handling, and increased productivity and efficiency.
As industry has been looking to reduce costs, improve efficiency, the FDA has begun to more closely scrutinize the industry’s 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.
Why should you attend
- To understand the compliance and quality requirements for reducing incoming material testing on pharmaceutical and medical device components.
- To gain knowledge applicable to the control and qualification of suppliers that will increase compliance and improve efficiency
- To reduce costs and increase efficiency in the handling of incoming materials and 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
Howard T. Cooper enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA.
His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations.
He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.