PDA Southern California: 9th Industry Summit & Exhibitor Showcase (Vendor Night)

Vendor Night Technical Session

Company Culture Drives Performance

To achieve high quality and optimal performance it’s important to recognize that the culture of a company plays an impactful role in that process. Our speakers and keynote will be reinforcing the significance of developing that culture.

Featured Keynote Speaker

Chinmoy Roy
Sr. Industry Consultant & Subject Matter Expert (SME) in Engineering & Quality Systems

“Strategic Quality Management: A Systems Approach for Continuous Improvement”

A key factor for achieving US FDA’s “Case for Quality” objective is to utilize the Strategic Quality Management approach.  Under this approach, Quality is viewed as a continuous improvement process where organizations are seen as the integration of the 5ps of Quality into the organizations’ operations. With advances in research resulting in discoveries of complex molecules, increased complexities in manufacturing sciences and industry’s march towards individualized therapies, business expediency requires the biopharmaceutical industry to adopt an agile and flexible approach to Quality. The presentation will outline the current industry practices to meet the evolving Quality challenges, manufacturing and business processes in a Pharma 4.0 operational environment including management’s role in defining a strategic Quality Culture.

Featured Technical - Sessions Speakers

Cylia Chen
Co-leader of PDA Quality Metrics/Culture Task Force Team

"PDA's Journey In Understanding Culture Of Quality"

Just like many other industries, biopharma and device industries are facing increased pressure for higher productivity and lowering cost, this results in employee strain and the likelihood of error in the day to day operations. In addition, there are recent examples of product quality issues in the marketplace that resulted in drug shortages and in some cases caused severe harm to patients. For these reasons, both industry and regulators are starting to recognize that organization's culture plays a critical role in cultivating a high performing company. This presentation will discuss the importance of culture of quality and PDA's research and learning on this topic.

Lisa Dierl
Vice President, Corporate Quality, Amgen Inc.

"Why Company Culture Matters"

For years companies focused on having the right strategy and figured company "culture" would follow – it did 't. Culture initiatives do not happen organically or on their own. It must be a concerted effort to ensure companies capture the essence of their culture, communicate this at ALL levels of the organization and how they can try and make "it" better. What is that "it" that they want to make better? It is no special pill you can buy, it is key behaviors we agree upon and recognize/reward to reinforce and drive this culture. This presentation will discuss the numerous benefits of culture, its importance and how to build it.