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The contents of ISPE’s guidance documents, both printed and digital, are protected by law and intended solely for the personal non-commercial use of the individual purchaser.

Reproduction of multiple copies of these materials, in whole or in part, for the purposes of commercial distribution is prohibited.

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USFDA GMP Inspection Approach for Laboratory Control Systems
USFDA GMP Inspection Approach for Laboratory Control Systems
USFDA GMP Inspection Approach for Laboratory Control Systems
This highly-interactive, pre-recorded online course reviews the laboratory control system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. This online course introduces laboratory controls, breaks down GMP Part 211, reviews method validation and out of specification results, and provides tips for laboratory notebooks. It also reviews requirements of laboratory equipment, gives insight on laboratory-focused, FDA systems-based inspections, and the common finding of non-compliance.

The course includes pre- and post-assessments, a downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all Web links discussed. At the conclusion of this session, participants will be able to:
  • Explain how to stay current and compliant with FDA regulations
  • Describe the Golden Rule on procedures
  • Describe the difference between GMP and GLP
  • Describe the minimum number of qualified personnel and supervisors to run quality control operations
  • Identify the requirements for proper record keeping and documentation in laboratory notebooks
  • Describe the GMP equipment requirements
  • Define method validation

    • 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: Analytical Procedures, Clinical / Investigational Products, Research and Development

    • Developer Biography
    James C. Gerner, Ed.D, M.S., M.T. (ASCP) is qualified by 20 years of experience as an independent consultant in the Food, Pharmaceutical, Biotech, Biopharm, Clinical Research Organization, IVD firms, Compressed Medical Gas, Blood and Medical Device Industries, 164 years in the pharmaceutical manufacturing environment, 6 years of hospital laboratory experience, 11 years of management experience, and currently teaches Biology and Microbiology at Northern Kentucky University. James is a registered Medical Technologist - M. T. (ASCP), and his education includes a B.A. in Medical Technology, M.S. in Curriculum and Instruction and an M.S. in Clinical Microbiology, and a doctorate degree, Ed.D., in Corporate Training and Development. Dr. Gerner has experience and expertise in the areas of cGMP training and auditing and has designed, developed, implemented and evaluated GMP programs for upper management, middle management, operators, maintenance, warehouse and distribution personnel, engineers, quality assurance personnel and support departments. Dr. Gerner has conducted GLP and GCP training and laboratory training for chemists, scientists, analysts and laboratory technicians. Dr. Gerner has conducted many training needs assessments and has worked with companies to develop their compliance training systems. He has also worked with companies to develop and implement their Quality System and has provided them with training and expertise on SOP writing and targeted GMP training. Another area of expertise is working with companies to implement Job Competency Models and Job Certification Programs.
    Discounted member price: 250.00
    480.00
    You could save 47.9%

    This highly-interactive, pre-recorded online course reviews the laboratory control system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. This online course introduces laboratory controls, breaks down GMP Part 211, reviews method validation and out of specification results, and provides tips for laboratory notebooks. It also reviews requirements of laboratory equipment, gives insight on laboratory-focused, FDA systems-based inspections, and the common finding of non-compliance.

    The course includes pre- and post-assessments, a downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all Web links discussed.


    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
    Non Member Price: $ 480.00
    Item #: WEBPRELCSUS