Brussels Training, 5-8 May 2014

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

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

Date

Location

Country

Instructor(s)

21 - 22 May 2014 Brussels Belgium Ms. Stephanie A. Wilkins, PE
3 - 4 Dec 2014 Tampa, FL USA Ms. Stephanie A. Wilkins, PE

Description

As global regulatory agencies are moving toward a scientific risk-based approach to determining the need for dedicated facilities, manufacturers need tools to meet these expectations.  Many manufacturers when they properly apply the tools can reap reduced cost and increased efficiency. This becomes especially important for contract manufacturing organizations (CMOs) where the ability to safely produce many different products within their facilities is a business necessity.  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.

The key is to understand your risk of cross contamination and be able to present scientific justification to regulators and auditors worldwide through scientifically based risk assessments that identify the need for risk controls.  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 course will focus on using 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
  • Regulation and Governance Documents
  • Risk Assessment
    • Risk identification and setting limits
    • Risk identification - cleaning
    • Risk Analysis – gathering data
  • Risk Management Tools
  • Risk Analysis
  • Risk Evaluation
  • Risk Control
  • Risk Review

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

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 one week prior to the start of the training event.

At the conclusion of this Webinar, participants will be able to: 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 course, 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 Containment ISPE Community of Practice (COP).

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses.  CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.  Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials.  Statements of credit will be available for download in your ISPE account within four weeks of the completion of training.  Instruction for download will be sent when the CEUs are available.  One hour of education programming equals 0.1 ISPE CEU credits.


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