Q-CULTURE

Course description

There should be a strong presence of culture awareness in quality within every regulated company even in the absence of a quality professional’s presence.

An excellence-led quality culture (Q-Culture) is, of course, fundamental in making a product that’s safe and effective in order to improve patient lives. It is also important to have in order to standardize and maintain consistency and retain a prouder and more fulfilled team. If your organization always has that in mind, odds are you already have a strong quality culture.
But if not, then there is a chance that your organization has anchored a compliance-led Q-Culture? This can lead to silo thinking, reactionary type behavior. It puts quality professionals (QuPs) in the center of establishing and following a Q-Culture in which rest of the organization sits on the side-lines and tends to keep out of it.
In any organization, Q-Culture should always be SHARED RESPONSIBILITY. There is no doubt about that.

Leaders must not only establish this direction (i.e., creating the way, definitions, frameworks, and implementations), but also BE the direction (i.e., Courageous, Put their money where quality is, Trustworthy, Supporting, Empowering)

Course outline

In this course, Leaders will be introduced to:

What Is Q-Culture?

• Why the Focus?
• Importance
• Who Creates Q-Culture?
• How Is Q-Culture Created

Core Elements

• Accountability at All Levels (incl. QuPs*)
• Leadership (their roles)

Exercises on defining Q-CULTURE for your Organization                

Before you Improve the Q- Culture Pillars (framework)

• Understand why Changing Culture is Hard
• What Must Be Influenced to see Desirable Change
• Best Strategies (know your tools vs behavioral strategies) Acute Quality Challenges***
• Milcor Consulting examples on how to improve
• Group exercises to improve selected challenges (end of day 1 and continued through day 2)

This lesson is 60% theoretical and 40% practical (Working groups assigned).

*QuPs stand for all Quality Assurance & Compliance Professionals (from new to principal specialists/experts & middle management)

*** Attendees will send in a max of 3 challenges that have been a struggle at their facilities in which they would like to find a way to improve during the group exercise part of the course. Late submittals may have to wait until the course to present their challenges (if there is time to cover).

This lesson is 65% theoretical and 35% practical (Working groups assigned).

Learning Objective:

By the end of the 1.5 day course, attendees will understand their role in Q-Culture, and be able to spot the areas in which improvement should be investigated further. There will be workable behavioral strategies/models that could be taken back to implement for reestablishing a culture in which the organization stives for more excellence-led vs compliance-led.

Who Should Attend:

This course is intended for:

• All Leaders overseeing Life science Personnel:
• Executive & Senior Leadership responsible for shaping culture of organization
• Team Leaders and Management within Quality Assurance and/or Production/Product Supply/Procurement/Supply Chain
• Managers responsible for change management, strategic operation, stakeholder management, training and/or global communication
• Team Leaders and Management within Regulatory Affairs and Research and Development should also attend.

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