|22-23 May 2013||St. Louis, Missouri||USA||Steve Wisniewski|
|22-23 May 2013||Brussels||Belgium||Alice Redmond|
|9-10 December 2013||Tampa, Florida||USA||Michael Porter|
Regulators expect that Quality Risk Management (QRM) is inherently built into the backbone of the Quality Management System (QMS) by using both formal and informal risk tools based on ICHQ9, however, the application and the complexity of the tools needs to be appropriate to the timing of the risk event, the level of risk and the elements of the QMS under scrutiny. The criteria for risk ratings and mitigation requirements should be clearly defined in advance of commencing the risk assessment. With the necessity to track and monitor the outputs of risk assessments and use them for the purposes of trending and the development of the site risk management file and risk dashboard, risk communication is key in the overall QRM process.
QRM principles require that the evaluation of risk to quality is based on scientific knowledge and the protection of the patient. In so doing the level of effort, formality and documentation of the QRM process is commensurate with the level of risk and the overall approach should be defined in a formal Risk Management Plan (RMP) for the site. To date the application of ICHQ9 is evident in risk based approaches to C&Q but to a lesser extent holistically throughout the product lifecycle.
Through interactive workshops, this course will explain and apply the key principles of QRM programs that need to include Quality Systems elements (ICH Q10) within the product/system lifecycle, including but not limited to:
Immediately apply the course objectives using the complimentary copy of the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification and the ICH Q8R2, ICH Q9 and ICH Q10 booklets.
NOTE: It is strongly recommended that participants should be familiar with basic concepts of ICHQ8 R2, ICH Q9 and ICH Q10 and a fundamental understanding of risk-based C&Q prior to attending this course. The course will not focus on the detail of the tools but the overall Risk management process. However worked examples of different tools will be given to enhance learning and understanding.
We recommend participants complete the primer course webinar that provides the background for the origins of the ICH guidelines, Q8 (R2), Q9, Q10 and the basic concepts of risk-based C&Q to provide a foundation to the QRM process.
This course includes the primer webinar. Access information will be provided via email one week prior to the start of the training event.
This training course is of particular interest to existing and future members of the Commissioning and Qualification ISPE Communities of Practice.
This course contains knowledge related to the CPIP™ technical knowledge competency element Facilities and Equipment: Commissioning and Qualification. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.
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.