Our journey from compliance to quality is rooted in deep traditions, but are those traditions helping us or hurting us? Focusing solely on inspecting for compliance is not sufficient to prevent drug shortages nor ensure drug quality. This talk discusses the quality management maturity (QMM) model, how to move to a culture of quality, common areas of improvement, what to expect.
1. The regulatory push (CDER/CBER/FDA/FDASIA): The future is quality criteria driven.
• The challenge of producing metrics at global scale.
• The QMM model and the evolution which began in compliance.
2. How to move from quality metrics to a culture of quality.
• Using data to understand improvement opportunities and drive your organization toward quality goals.
• Strong quality cultures are the foundation that drives improved performance through efficient processes and investment in the impact of data and analysis.
3. Quality attributes and quality behaviors.
• What does an organization with a mature QMM model look like?
• Techniques to shift the conversation and mindset of an organization with a QMM model.
• Determining where you are on the spectrum of evolution, what to expect, and what to look forward to.
The experts at Pharmatech Associates can help you navigate the ever-changing world of regulatory compliance.
Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.
22320 Foothill Blvd. Suite 330, Hayward CA 94541