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Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline® Guide (T41)

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Level: Intermediate
Type: Classroom Training Course
ISPE CEUs: 1.4
Includes Webinar Webinar Mouse Icon

Date Location Country Instructor(s)
29 February-1 March 2012 Tampa, FL USA Stephanie Wilkins

Description

As manufacturers are looking to reduce cost and increase efficiency, more multi-product facilities are being utilized either directly by the manufacturers or through partnerships with contract manufacturing organizations (CMO’s). With the use of multi-product facilities, the risk of cross contamination increases. By properly managing the risk of cross contamination,manufacturers can reap the benefits of lower cost and higher efficiency while maintaining product quality and patient safety.

Immediately apply the course objectives using the complimentary copy of the ISPE Baseline Guide: Volume 7 Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP).

The key is to understand your risk of cross contamination and be able to present scientific justification for the methods used for risk assessment as well as risk control strategies to regulators and auditors worldwide.  ISPE’s Baseline® Guide: Risk-MaPP, helps companies manage their risk of cross contamination by outlining a scientific, risk-based methodology based on ICH Q9 that can be used to lead teams through the process to satisfy auditors as well as global regulators.  This introductory session will focus on use of the logic diagram, how health based limits are developed, setting cleaning validation limits, risk assessments for cross contamination and formulating a Quality Risk Management Plan as part of a Quality System.

Course Modules

  • Overview of ICH Q9 and how Risk-MaPP fits in
  • Introduce the Logic Diagram
  • Risk Assessment
    • Risk Identification and setting limits
    • Risk Analysis – gathering data
    • Risk Evaluation – comparing identified and analyzed risk against risk criteria
  • Risk Control
    • Risk Reduction
    • Risk Acceptance
  • Risk Management Tools
  • Regulations
  • Governance documents and ICH Q10
  • Pulling it all Together
  • Risk Review
  • Risk Communication

Includes Webinar 

This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. You will receive information via email on how to access the Webinar two weeks prior to the start of the training event.

Webinar Learning Objectives

This webinar 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. In preparation for the course, the webinar will review the history of Risk-MaPP and what it is; why it is important along with why it is needed and fits into the regulatory landscape.

Take Back to Your Job

At the conclusion of this session, participants will be able to:

  • Determine when multi-product facilities can be used
  • Use the logic diagram to guide a team through the process of determining how to manage the risk of cross contamination
  • Understand where to get health-based data for use in risk assessments
  • Develop scientific risk-based cleaning validation limits
  • Prepare a Quality Risk Management Plan for Cross Contamination

Attendance Suggested For

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).

Community of Practice (COP)

This training course is of particular interest to existing and future members of the following ISPE Communities of Practice (COP).

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.