Auditor is a seasoned expert in biotechnology with over 12 years of experience as a former FDA Investigator. His background includes auditing pharmaceutical manufacturing processes, compliance, and quality assurance. He has conducted audits on various pharmaceutical products, including sterile injectables, biotech products, and oral dosage forms. He specializes in risk-based audits, batch record reviews, and stability study oversight for regulatory submissions. He also offers regulatory compliance recommendations and remediation solutions to pharmaceutical companies worldwide. His extensive experience covers clinical trials, human subject protection, and compliance with 21 CFR part 11 regulations. He is proficient in Castilian Spanish and Brazilian Portuguese, and he has received multiple FDA awards for his contributions. He is also the author of "Bubble gum badge an FDA His-Story."