-A shared responsibility with a behavioral twist

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.

This lesson is 90% theoretical and 10% practical (Mentimeter for questions).

Course outline

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

Core Elements
• Leadership (their role)
• Accountability at All Levels (incl. QuPs*)

Before you Improve the Q- Culture
• Understand why Changing Culture is Hard
• What Must Be Influenced to see Desirable Change

A Behavior-Based Continuous Improvement Model

Learning Objective:

By the end of the half 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:

• All Quality Compliance Personnel: Team Leaders and Management within Quality Assurance and/or Production/Product Supply
• Specialists, Professionals, and/or Project 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.
• Risk management personnel, Compliance, and/or Health and Safety specialists.









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Date & Time
09.00 - 11:30 CET
IndustryCombination products, Medical Device, Pharmaceuticals

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In-House Training

This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.

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Your Instructor(s)

Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.

Energy Kristina Hansen



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