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.
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.