2013 Tampa Training, December 2014

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Managing Cross Contamination with Risk MaPP Training Course

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

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

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.   This becomes especially important for contract manufacturing organizations (CMOs) and generic firms 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.

Additional course content will cover:

  • Updated EU GMPs relative to managing the risk of cross-contamination and guidance provided by the EMA to pharmaceutical industry on how to set health-based limits that would be used in the risk management process to determine if shared facilities can be used. This guidance also states “PDE and ADE are effectively synonymous”. 
  • Adoption by U.S. and EU regulators of a “life cycle” approach to process validation incorporating stages of process design, process qualification, and continued process verification. The Process Validation Lifecycle recognizes that validation is an ongoing control strategy to manage risks and maintain process control. The concept of ongoing assurance of cleaning process efficacy is one of the keys to control the cross-contamination discussed within the course. 
  • In-depth review of the appendix examples.

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

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

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) OSD, API, PM, Biotech and Sterile.

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DatesLocationsInstructors 
06 Nov 2017 -
07 Nov 2017
Tampa, FL USA Ms. Stephanie A. Wilkins, PE
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Fees and Daily Schedule

TypeOn or Before
07 October
After
07 October
Member US$1,835 US$2,035
Nonmember US$2,230 US$2,430
Government US$1,010 US$1,120
Daily Schedule at a Glance
07.30 – 17.00 Registration Open
08.30 – 17.00 Training Course
10.00 – 10.30 Refreshment Break
12.00 – 13.00 Lunch
14.30 – 15.00 Refreshment Break

Group Discounts

  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
  • 11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

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