Meet Our Founders
Brian Klotz
Co-Founder and Principal Consultant
Validation and Quality Systems Consultant with over 30 years of experience in highly regulated industry. Knowledgeable in 21CFR820, ISO 13485, and ISO 9001 Quality Management Systems. Experienced Lean Six Sigma Black Belt who delivers operational excellence through creative, least-burdensome applications of TPS concepts. Strong technical and analytical capabilities enable adept and efficient leadership in specialized validation (software, design, process, etc.). Expert in statistical process control, data analysis, and continuous operational improvement.
Nathan Zarnstorff
Co-Founder and Principal Consultant
Qualification and Validation Expert. 10+ years in quality engineering, quality assurance, manufacturing engineering, and Sterility Assurance roles in cGMP manufacturing environments. Skilled in risk management, test method development, validation strategy, and manufacturing quality systems development. Relentless ideator, continuous improver, life-long learner, and passionate believer that long term goals are just excuses to procrastinate.
Yahaira Pabellon
Co-Founder and Principal Consultant
Experienced engineer with over 14 years of dynamic experience spanning the Nuclear, Pharmaceutical and Medical Device industries. Armed with a bachelor’s degree in mechanical engineering and an unwavering commitment to improvement, Yahaira has spearheaded numerous quality and continuous improvement initiatives in highly regulated sectors. Profound expertise in Root Cause Investigations, Validations, Equipment Qualification, Error Reduction, CAPA, and Supplier Quality.
Israel Perez
Co-Founder and Principal Consultant
A seasoned Quality Assurance professional with 15+ years of comprehensive experience in cGMP environments. Possessing strong expertise in Quality Control, Quality Assurance, Supplier Quality, Manufacturing, Equipment Qualification, Process Validation, and Training. Demonstrated proficiency in systems like Trackwise, Smartlab/LIMS, Success Factors LMS, SAP, and more. Proven track record in Investigation/Deviation Management, Change Management, Validation, and Qualification, with a dedicated focus on Risk Management and Validation & Verification.