Howard Cooper
Instructor Howard Cooper
Product Id 600541
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Establishing a Reduced Testing Program for Pharmaceutical & Medical Device Components

Overview:

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: Only you can determine the need to attend this webinar. I would like to offer a suggestion. Why not review the principles explained in this informational packet and then compare your system structure to the elements outlined here. If your system includes all of these elements, that's great. Then, join us to learn a new perspective. However, if you see some potential vulnerability, please join us to learn more and gain insight for improving your reduced material testing program.

This course will help you understand the lifecycle for the reduced testing of pharmaceutical and medical device components. This lifecycle begins by explaining the steps of a successful reduced testing program that include material qualification, general supplier qualification, supplier qualification for reduced testing, establishing criteria for sampling, role of validation, the role of the laboratory, test methods, comparing analytical results, analyzing the Certificate of Analysis (COA), and monitoring to ensure continued compliance with the regulations. This understanding of the lifecycle will help you confidently present arguments to management for establishing, designing, training and implementing, and managing the reduced testing process.

Areas Covered in the Session:

  • A Brief Quality Lesson
  • Defining the Reduced Testing of Components Environment
  • Regulatory Requirements and Current Industry Practices for Reduced Testing.
  • Advantages and Disadvantages of Reduced Testing
  • Players, Roles, And Responsibilities-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.
  • A Risk Based Sampling Plan To Determine Sample Size and Frequency
  • Planning for Implementing a Reduced Testing Plan
  • Implementing a Reduced Testing Program
  • Action Steps
  • Maintaining The System
Who Will Benefit:
  • Material Laboratory Managers & Personnel
  • Incoming Warehouse
  • Purchasing & Production
  • Quality Assurance Managers

Speaker Profile
Howard 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.

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