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Establishing a Reduced Testing Program for Pharmaceutical & Medical Device Components - Webinar (Recorded)

  • Webinar

  • 90 Pages
  • November 2018
  • World Compliance Seminar
  • ID: 4629735

Includes All the Training Handouts, Certificate by the Speaker, Q/A and a 90 Min Live Webinar

This training will help you understand FDA expectations for reduced testing of Pharmaceutical & Medical Device components and will develop your confidence in maintaining control of supplier quality.

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

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

Agenda

Areas Covered

  • Requirements for material qualification.
  • Key elements of an audit that help understand the supplier’s ability to produce a 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.

Speakers

  • Howard Cooper
  • Mr Howard Cooper,
    President ,
    EQACT, INC.


    Howard Cooper is an independent quality and regulatory consultant with more than 40 years of hands-on, tactical, and strategic experience designing, implementing, managing, and remediating device, pharmaceutical, and biological quality systems. His technical background helps him understand and apply the technology, his political science helps him understand the regulatory process, and his work on an MBA provides a business perspective. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Certified Quality Auditor (CQA).

    After teaching high school science, Howard joined Anheuser-Busch as a Management Quality Trainee to begin his FDA experience. His ability to quickly learn and apply quality principles resulted in promotions to quality supervision and management. He transferred this experience to a medical device contractor about the time FDA medical device regulations were on the horizon. He applied his comprehensive quality experience to revamp both quality and operations to meet all regulations the ride for the medical device amendments.

    As a change agent, he enjoys challenging and persuading others to think outside the box to view quality as a positive and energetic force that can make the difference between business success and failure. He emphatically emphasizes the importance of competent and confident people who develop strong working relationships as they work to constantly improve the organization.

    Since becoming a consultant in 2004, he has focused on startup and problematic operations using his “change agent mentality”. During presentations, he frequently relates these experiences to illustrate how he mitigated and resolved issues.

    Howard particularly enjoys and encourages class participation and discussion during the presentation.

Who Should Attend

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

Industries who can attend

This online course is intended for professionals in all Industry. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel.