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Gain Proficiency in Quality Risk Management

by Emma Ramnarine, Genentech/Roche, and Stephanie Ko, PDA | Oct 03, 2017

PDA’s New Role-based QRM Certificate Program Offers Courses for all Levels of QRM Involvement

Risk management may not be in your official job description, but do you find yourself assessing risks when making decisions in your day-to-day activities, even if you do not document it formally? Have you participated in a risk assessment and want to improve? Would you like to learn when, where and how to apply quality risk management (QRM)? Are you interested in understanding what good risk-based decision-making means and how it can be achieved?

If you answered “yes” to any of these questions, you will certainly want to take advantage of PDA’s new, first-of-its-kind, role-based “QRM Certificate Program” developed by leaders in QRM. This certificate program is accredited by the Accreditation Council for Pharmacy Education (ACPE) and will be accredited by the Dublin Institute of Technology (DIT).

ICH Q9, Quality Risk Management has been effective since November 2005, yet industry and regulators have still not fully realized its vision and value. While there are various reasons, one foundational explanation is the gap in QRM skills. Since ICH Q9 was published, the primary focus has been on the QRM process and risk assessment tools, while very little attention has been paid to the various roles in the QRM process or developing the skills for each of these roles. Just like different actors have distinct parts in a play, there are different roles in the QRM process, so the program has been designed with this in mind.

This certificate program is a modular training course with tiered tracks (Figure 1). The first series of classes is being offered Dec. 11–14 at PDA TRI.

Foundations for QRM Course
Figure 1 Foundations for QRM Course
  • QRM Foundations Track: This track is designed for all personnel involved in QRM as a participant in risk assessments, QRM facilitator or decision-maker, such as personnel from QA, QC, engineering, validation, production and technical services who are involved in QRM activities. This course is a prerequisite for the tracks listed below.
  • QRM Decision Maker Track: This track is applicable to supervisors, managers and directors from disciplines such as QA, QC, engineering, validation, production and technical services, who often make decisions based on the outcomes of risk assessments for their areas of responsibility.
  • QRM Application Track: This track is applicable to pharmaceutical professionals engaged in QRM application activities related to CMC for pharmaceutical/biotechnology processes, such as manufacturing supervisors, managers and directors; process development biochemists; microbiologists; cell biologists and molecular biologists; etc.
  • QRM Facilitator Track: This track, to be offered in 2018, will be the most comprehensive of the four tracks. It is applicable to individuals expected to be highly skilled and proficient in the entire QRM process and its application, including the use of various QRM tools. QRM facilitators may be involved in various functions across an organization including project management, operational excellence and technical functions.

The benefits that companies can expect to get from this program include:

  • Increased alignment in QRM application across the industry
  • Reduced internal QRM training efforts
  • Improved sharing of QRM application knowledge between companies
  • Fully realized QRM application for companies with QRM programs at all maturity levels

For more information, contact Stephanie Ko or David Talmage.