Helping Establish Your Quality System
Develop Your Path to Sustainable Compliance
At MCGetz Consulting, our business is helping your business be compliant. Whether you need help with developing a Quality Management System or remediating a subsystem, we’ve got a strategy for you.
We have a proven track record of implementing successful Quality Management Systems within Medical Device and Pharmaceutical companies. Our focus has been that with proper planning and building in quality, your business can be both compliant as well as cost-efficient.
Biography
Dr. Getz has over 30 years of industry experience, which includes wide ranging expertise in developing quality, compliance, and regulatory strategies for the Medical Device and Pharmaceutical industries. Her experience includes 20 years at various Johnson and Johnson (JNJ) subsidiaries, starting in a microbiology lab at Ethicon and working her way up to VP of Quality and Compliance at both Neutrogena and Biosense Webster. From there she went to Quest Diagnostics, where she oversaw both the CLIA lab as well as the IVD business as the VP, Quality, Regulatory and Clinical Affairs for the FOCUS Diagnostics business unit.
Since leaving industry, she worked for PwC and NSF (formerly Becker & Associates) within Life Science consulting, focusing on Pharmaceutical and Medical Devices. Her systems-based approach has resulted in effective Quality System development, remediation, and implementations. Dr. Getz continues to take a streamlined and focused approach which leads to more cost-effective and sustainable results.
Since 2013 and the issuance of 21 CFR Part 4 Regulations for Combination Products ruling, she has routinely engaged with FDA leadership in the Office of Combination Products (OCP) as well as within CDRH and CDER agencies. Dr. Getz has published several white papers, chaired workshops and conducted webinars along with countless cross-functional training sessions on the Part 4 regulations and how to develop and implement the right compliance strategy. Pharmaceutical clients who followed that compliance strategy had no Part 4 FDA 483 observations!
With her Microbiology background and diagnostic experience, she has expertise on IVDs as well as LDTs and understands the regulatory challenges of each. Dr Getz has conducted trainings for various start-up companies as well as successfully guide them on new IVD product launches.
Dr. Getz received her PhD in Microbiology and Molecular Genetics from Rutgers University and has a Six Sigma Black Belt Certification.