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USFDA GMP Inspection Approach for Materials Systems
USFDA GMP Inspection Approach for Materials Systems
USFDA GMP Inspection Approach for Materials Systems
This highly interactive pre-recorded online course reviews the Production System and its importance within the USFDA Systems Inspection Approach. Review the materials system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. Materials system elements reviewed include a basic understanding of the controls required for a materials quality system, including issues related to automated systems and the concepts of supplier qualification and the additional requirements for investigational products. At the conclusion of this session, participants will be able to:
  • Describe controls relating to receipt, identification, inventory, storage, sampling, testing and use of components, containers, closures, finished product storage and distribution controls
  • Identify purchasing controls for components, containers and closures as well as the automated systems related to materials handling and management
  • Describe the requirements for material handling in the control of investigational medicinal products and the purpose of the investigational new drug application

  • Attendance Suggested for:
  • Professionals who are new to the industry or have new work assignments that need to gain knowledge about the industry, its challenges and regulations.
  • Professionals with industry experience that want a refresher.
  • Suppliers and service providers to the industry, who design, construct, validate and finance facilities.
  • Individuals who support the industry through training, marketing, economic development and personnel placement.
  • Individuals with responsibility for: Clinical / Investigational Products, Logistics / Supply Chain Management, Quality Assurance / Control, Regulatory / Compliance

  • Developer Biography
    Kate McCormick, PH.D. of Heathside Information Services Ltd, UK, is a manufacturing consultant with extensive strategic and operational management experience in the pharmaceutical industry, both in the U.K. and internationally. Kate has 10 years of line management and 20 years of internal and external consulting experience. She has worked with multinationals, SMEs, non-governmental organizations and national regulatory authorities in more than 50 countries. She is the author of Quality (a textbook within the Butterworth Heinneman pharmaceutical engineering series) and Manufacturing in the Global Pharmaceuticals Industry, the editor of gmp Review and a regular speaker at international conferences. Kate gained a degree in biochemistry and a doctorate in microbiology, both at London University. She also has a Masters in Business Administration. She is registered as a senior GMP expert within the EU and is eligible as a QP under the terms of the EU directive. She is currently European Education Advisor for ISPE.
    Discounted member price: 250.00
    You could save 47.9%
    This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

    ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

    Approximate Course Duration: 60 minutes (this is a self-paced course)

    *NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

    ISPE CEUs: .10 ISPE CEUs will be awarded upon successful completion of grading requirements

    Member Price: $ 250.00 / € 205.00
    Non Member Price: $ 480.00 / € 394.00
    Item #: WEBPREMSUS