From CAPA to Capability: Shifting the Focus to Profitability

Naturally, that works well for remediation efforts, however, by focusing instead on your core processes and systems, you can unlock opportunities for growth and profitability. Adopt a proactive approach to quality and learn how you can mitigate risk, decrease the likelihood of warning letters, and most importantly, improve your operational efficiency, embrace Right-First-Time (RFT), and dramatically improve your bottom line. Using practical examples, this webinar will help you look holistically at your quality systems and embrace a continuous improvement approach that will drive quantifiable business benefits.

Areas Covered in the seminar:

1. Proactive vs. Reactive Approach
• Why compliance-driven initiatives don’t work
• Money matters - the cost of waiting
• Establishing a strategy for quality


2. Measuring Quality
• Identifying key metrics
• How quality impacts profit


3. Continuous Improvement
• Effectively combining quality systems initiatives with continuous process improvement
• Using metrics to continuously improve
• Keeping a focus on Right-First-Time (RFT)

Who Will Benefit:

This webinar will provide valuable assistance to all regulated life sciences companies including pharmaceutical, biotechnology, medical device, and diagnostics. Those that would benefit most within the organization would include:

• QA/QC Managers and Directors
• VPs of Quality, Operations, or Manufacturing

Instructor Profile:

Barbara Johnson is a manager for Clarkston Consulting and leader of their Regulatory Planning and Remediation solution. With over 25 years of progressive experience in the information systems industry and over 11 years of expertise specifically within the biologic and pharmaceutical industries, she is an accomplished project manager. Prior to joining Clarkston Consulting, she worked as a regional manager with the information technology consulting services group of a large professional services firm. Her recent management experience spans quality systems initiatives, project management office implementations, and systems development life cycle processes. She has also led manufacturing, laboratory and enterprise resource planning process optimization as well as auditing, assessment, and analysis of compliance-related issues. Beyond industry expertise, she holds professional certifications from American Management Association, Institute for Validation Technology, Parenteral Drug Association, Project Management Institute, George Washington University, and Projecting Success, Inc. She received her B.S. in business management from the Rochester Institute of Technology.

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