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Navigating a QMS Integration - A Road Map through the Trenches

Thursday 15 June 2017

On May 16, 2017, Stephanie Gaulding, Principal Consultant, Quality and Regulatory Compliance with DPS, presented on integrating quality management systems at ASQ Raleigh’s Annual Quality in the Triangle Conference. Mergers and acquisitions are a common way pharmaceutical and biotech companies strengthen or diversify product portfolios and production capabilities.  Stephanie discussed some of the key factors in successfully integrating quality management systems highlighting lessons she has learned in leading several integrations.

Stephanie has over 20 years of experience in quality systems and validation program management in FDA- and EU-regulated companies with over 3 years providing quality and regulatory consulting services. She has held various site Quality Management positions with responsibility for development, redesign, streamlining, and implementation of phase-appropriate quality systems and validation programs to comply with global regulatory requirements and industry best practices for drugs, biologics, and medical devices.

Stephanie is an ASQ Certified Quality Auditor and ASQ Certified Pharmaceutical GMP Professional. She is also an active member of PDA, ISPE, and ASQ including co-teaching the ISPE “Applying Quality Risk Management” course, serving as an ASQ technical community member leader, and participating in the Certified Pharmaceutical GMP Professional Exam development process.

In her role, she helps her clients develop, redesign and implement efficient and sustainable quality systems; successfully preparing for and navigating regulatory inspections; and implementing robust quality risk management programs. 

 

Click here to download a copy of the presentation:  Navigating a QMS Integration - A Road Map through the Trenches