Quality Culture at the Crossroads: Building a Culture of Quality for Increased Success – Webinar Recording/Transcript
If you dismiss “quality culture” as mere industry jargon, prepare to struggle. We’ve come a long way since the FDA’s 2014 quality metrics initiative led to a greater focus on quality culture. It’s no longer a nice-to-have; it’s an imperative.
Ingraining a robust quality culture brings efficiency, reliability and sustainable compliance to life science businesses just like yours. It means greater opportunities for success and fewer manufacturing problems in the long run.
And with both on-site and remote FDA inspections set to rise in 2022 thanks to a budget increase from Congress, now is the time to create a quality culture in your company. Or risk losing market share and competitive advantages … permanently.
While the original strategies primarily emphasized executive management’s role, best practices now dictate other tactics.
In this presentation, Susan Schniepp, distinguished fellow at Regulatory Compliance Associates®, will explain these approaches in how to build quality culture within your organization.
She will share why quality culture is a must; new quality culture tools and standards under development by the Parenteral Drug Association (PDA) and other organizations; and best practices, including case studies with lessons learned.
- Define the leadership objectives that must be at the root of quality initiatives
- Achieve buy-in so that employees accept and adhere to product integrity and ethical standards
- Encourage an open discussion of quality hazards at each stage of business
- Promote — and gain wide acceptance for — collaboration, and how to assess your team gaps
- Why commitment to professional development and quality training is critical to success
Until every single member of your team — and your organization — buys into increasing overall quality, you will fall behind. This presentation will enable you to build a quality culture that works.
Meet Your Presenter
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates®, Inc., is the knowledge leader responsible for training and advising RCA staff and clients on current trends and issues facing the pharmaceutical, biotechnology, and medical device industries. Her background includes cGMPs, audit readiness, change control, investigations, supplier quality and batch record reviews. Ms. Schniepp has more than 40 years’ experience in quality assurance, serving in leadership roles at Allergy Laboratories, Inc.; OsoBioPharmaceuticals LLC; Searle; Abbott; and Hospira. In addition, she has been on the Parenteral Drug Association (PDA) Board of Directors from 2011-2013 and 2016-2019 and currently serves as the Chair-Elect.
Who Will Benefit
- Quality Assurance Personnel (All Levels)
- Operations Personnel (All Levels)
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Jan. 13, 2022