Our Background

Luis F. Ortiz is a Chemical Engineer with a Master’s degree in Quality Management and over 30 years of experience in the food and pharmaceutical industries, specializing in process engineering, food safety, and regulatory compliance.

​

He is a Preventive Controls Qualified Individual (PCQI) and has extensive experience supporting companies in complying with U.S. FDA regulations, including FSVP (21 CFR Part 1 Subpart L) and Preventive Controls (21 CFR Part 117).

Luis has successfully guided organizations through FDA inspections, including preparation, response to FDA Form 483 observations, and implementation of corrective actions aligned with regulatory expectations.

​

Additionally, he serves as an instructor and speaker in the Better Process Control School, providing training and certification for supervisors of Low Acid Canned Foods Manufacturing Plants on thermal processing, food safety systems, regulatory compliance, sanitation, hermetically sealed containers integrity and double seams, and cGMP's. 

FDA INSPECTION SUPPORT

• FDA inspection readiness assessments

• Strategic support for FDA inspections

• Response preparation for FDA Form 483 observations

• Regulatory gap analysis based on FDA expectations

• Risk-based hazard evaluation and technical justification

 FSVP & SUPPLIER COMPLIANCE

• Development and implementation of FSVP programs

• Hazard analysis aligned with FDA preventive controls

• Foreign supplier evaluation and approval programs

• Scientific justification of hazard controls

• Importer of Record regulatory compliance

 FOOD SAFETY & PROCESS EXPERTISE

• Thermal processing and process validation

• Hazard analysis (biological, chemical, physical hazards)

• Preventive controls implementation (PCQI approach)

• GMP and sanitation systems evaluation

• Risk assessment based on engineering and scientific principles

PROFESSIONAL DISTINCTIONS

• Chemical Engineer with 30+ years of food and pharma industry experience

• PCQI (Preventive Controls Qualified Individual)

• Speaker and instructor at Better Process Control School

• Extensive experience in food and pharmaceutical manufacturing environments

• Proven track record supporting FDA compliance and inspections

• Member Institute of Food Technologists

• Member Institute for Thermal Processing Specialists