Establishing a Reduced Testing Program for Pharmaceutical & Medical Device Components

Why Should You Attend:

The FDA has begun to more closely scrutinize the industry’s effort in the qualification of suppliers and contractors. This is particularly true in the qualification of the supplier for a reduced testing program. When properly administered, a reduced testing program lowers the cost of testing and provides a higher level of quality.

The principles for pharmaceuticals and medical devices are the same but there are some differences due to the nature of the products.

This course will help you understand FDA expectations for reduced testing of components and will develop your confidence in maintaining control of supplier quality. This discussion begins with explaining, in stepwise fashion, the various steps required to have a successful reduced testing program. The primary steps include material qualification, general supplier qualification, supplier qualification for reduced testing, establishing criteria for sampling, the role of the laboratory, test methods, comparing analytical results, and determining the Certificate of Analysis (COA).

Areas Covered in the Webinar:

• Requirements for material qualification.
• Key elements of audit that help understand the supplier’s ability to produce consistent product.
• Evaluation of the audit results to qualify for reduced testing will be explained.
• The terms supplier reliability and supplier history will be placed into perspective.
• Sampling plans and minimum testing requirements.
• Explanation on how to analyze and compare laboratory results and make a determination about the acceptability of the supplier for the reduced testing program.
• Process for preparing the requirements for the COA, processing receipt of COA’s, and maintaining control.

Learning objectives:

• Understanding FDA expectations for conducting reduced testing programs
• Learning a process for evaluating and qualifying suppliers to participate in a reduced testing program
• Methods for analyzing and evaluating reduced testing data & supplier trending

Free handouts:

Diagrams explaining the subject matter will be provided.

Who Will Benefit:

This webinar will provide valuable assistance to all Pharmaceutical & Medical Device companies/ manufacturing sites. Those that would benefit most would be:

• Material Laboratory Managers & Personnel
• Incoming Warehouse
• Purchasing & Production
• Quality Assurance Managers
• Suppliers

Howard Cooper
Consultant, EQACT Inc

Howard Cooper, has over 40 years experience in the pharmaceutical and medical device industry creating, implementing, managing & remediating quality systems. This experience has shown his leadership, organizing & problem-solving skills to develop quality systems from scratch or in the role of a change agent to remediate failing systems. This experience includes small and large companies operating in the US, Europe and Japan. He has worked with a wide variety of FDA regulated products such as medical devices, in vitro diagnostic reagents and instruments, in vivo diagnostics, pharmaceuticals (Tablets, capsules, injectables), biologicals, monoclonal antibodies), and combination products.

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.

During experience described above, Mr. Cooper has implemented full supplier qualification systems and programs. This includes both consulting and employee roles.

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