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USFDA GMP Inspection Approach for Packaging and Labeling
USFDA GMP Inspection Approach for Packaging and Labeling
USFDA GMP Inspection Approach for Packaging and Labeling
This highly interactive online course reviews the Packaging and Labeling Systems and their importance within the USFDA Systems Inspection Approach. Understand the packaging and labeling operations in general and the processes and controls that must be in place. Identify the specific regulatory requirements that affect all elements of packaging and labeling. Know what is required before, during, and after the packaging and labeling of product. At the conclusion of this session, participants will be able to:
  • Describe the label reconciliation process
  • Identify the regulatory requirement for excess labels on specific lots, using on-line label printing equipment and for shipping records
  • List the types of printed materials that are considered labeling under the USFDA Food, Drug and Cosmetic Act
  • Define misleading and misbranded packaging and labeling
  • Explain the requirements for packaging materials
  • Describe the tamper resistance packaging requirements for over the counter products including the exemptions
  • Identify the steps in the packaging and labeling process that must occur before the final product is released
  • Explain the documentation and process requirements for line clearance

  • 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, Operations / Manufacturing, Process Control / Automation, Process Development / Technology Transfer, Project Management, Quality Assurance / Control, Regulatory / Compliance, Research and Development

  • Developer Biography:
    James C. Gerner, Ed.D, M.S., M.T. (ASCP). Dr. Gerner is qualified by sixteen 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, 14 years in the pharmaceutical manufacturing environment, 6 years of hospital laboratory experience, 11 years of management experience, and 2 years of experience teaching in the Biological Sciences Department at a University and a local college. 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. He 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
    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: 30 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: .05 ISPE CEUs will be awarded upon successful completion of grading requirements

    Member Price: $ 250.00 / € 205.00
    Non Member Price: $ 480.00 / € 394.00