|10-11 April 2013||San Francisco, California||USA||Stephanie Wilkins|
|22-23 May 2013||Brussels||Belgium||Stephanie Wilkins|
|5-6 November 2013||Washington DC||USA||Jim John|
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.
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 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.
Immediately apply the course objectives using the complimentary copy of the ISPE Baseline Guide: Volume 7 Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP).
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.
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.
At the conclusion of this course, participants will be able to:
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.
This training course is of particular interest to existing and future members of the following ISPE Communities of Practice (COP).
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.