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Risk-MaPP: What is it and Why You Need it!
Risk-MaPP: What is it and Why You Need it!
Risk-MaPP: What is it and Why You Need it!
This fundamental course will help you understand the “why,” what,” and “how to use” the ISPE Baseline® Guide, Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP). Risk-MaPP provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety. If you are involved with multi-product facilities, this information is an essential tool for you. At the conclusion of this course, participants will be able to:
  • What Risk-MaPP is
  • The history of Risk-MaPP
  • Why Risk-MaPP is important for multi-product facilities
  • Why Risk-MaPP is needed
  • How Risk-MaPP fits into the regulatory landscape

  • Attendance Suggested for:
  • Years in industry: 0-4 to 5-14
  • Anyone dealing with multi-product facilities especially QA, Toxicologists, EH&S professionals, Engineers, Operations, Cleaning Validation, Project Managers, Regulators/ Inspectors
  • NOTE: This course will expand upon some basic concepts in the following areas so attendees should be familiar with the basics prior to attending this session
  • Containment basics and the use of operator exposure limits
  • Setting cleaning limits (note this session will not discuss cleaning procedures, processes, etc)

  • Instructor Biography:
    Stephanie Wilkins Stephanie Wilkins, PE, Lean Six Sigma Green Belt, has over 29 years of professional experience in project management, risk management, engineering and validation solutions for the pharmaceutical/biotech industry including research, development, pilot plant and manufacturing facilities. She is President of PharmaConsult US, Inc, which provides cross-contamination and containment consulting to the pharmaceutical industry. Wilkins is the co-Chair of the ISPE Risk-MaPP Baseline Guide Task Team and was a member of the ISPE International Board of Directors. Wilkins also is a reviewer for articles to be placed in the Pharmaceutical Engineering Journal as well as contributed articles, given lectures and organized courses for ISPE. Wilkins graduated from the Pennsylvania State University with a Bachelor of Architectural Engineering.
    Discounted member price: 99.00
    Your price: 149.00
    You could save 33.6%
    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: $ 99.00 / € 70.00
    Non Member Price: $ 149.00 / € 110.00

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