Are you looking for ways to improve your level of quality and compliance? Maybe you are a startup or your company is expanding into handling a new product category. Possibly, you’d like to support your team resources without expanding internally. Need to chat with a consultant to assist with your quality and compliance needs? I can help with that!

I am an experienced quality and compliance professional with a demonstrated history leading quality, compliance, and regulatory efforts during my career. I have worked for the government with FDA and industry with pharmaceutical manufacturing and Consumer Packaged Goods (CPG) industrial hemp cannabinoid manufacturing. I have worked within various program areas and product categories ensuring compliance with applicable associated regulations through nonconformity identification and solution proposal or implementation.

• Drug active pharmaceutical ingredients and finished products (GMP, GLP)

  • APIs, oral solid dose, liquid, sterile, over-the-counter

• Bioresearch monitoring for drugs and medical devices (GCP, GLP)

  • clinical investigations, institutional review boards

• Dietary supplement ingredients and finished products (GMP)

  • dietary ingredients, powders, liquids, oral solid dose, gummies

• Industrial hemp derived cannabinoid ingredients and CPG (GMP, GLP)

  • extracts, supplements, cosmetics, companion animal supplements, UK/EU novel food application submissions

• General Food (GMP)

  • food ingredients and ready-to-eat (RTE) food

I started my career in compliance working for the U.S. Food and Drug Administration (FDA) as a Consumer Safety Officer - Investigator where I gained invaluable knowledge, skills, and experience in FDA law and regulations. I traveled domestically on independent and team assignments across program areas such as, bioresearch monitoring (BIMO), drugs, dietary supplements, and general food. I achieved voluntary compliance on most occasions including voluntary recalls. I have also been involved with warning letters issued to sites inspected, review of responses, and follow-up. I followed regulations and guidance including, but not limited to, 21 CFR 11, 50, 56, 110, 111, 117, 210, 211, and ICH Q7.

I conducted drug manufacturing audits, acquisition due-diligence, and FDA readiness projects for Teva Pharmaceuticals manufacturing of various dosage forms. I traveled to Teva sites and suppliers globally in approximately 30 countries requiring compliance with US FDA and various countries’ ministries of health regulations and normatives such as, 21 CFR 11, 210, 211, 600-680, and ICH Q7.

I held Quality leadership positions at two Colorado based industrial hemp cannabinoid ingredient and consumer packaged goods (CPG) companies, Charlotte’s Web and Mile High Labs, focusing on quality assurance, quality control, and regulatory affairs. This involved domestic and international work within a constantly evolving patchwork of regulations mostly led by states within the U.S. and various international regulatory agencies. I ensured compliance with state and FDA regulations including, 21 CFR 11, 111, 117, and 507, as applicable. I ensured registrations and certifications were attained and maintained with independent standard such as, NSF, NASC, SGS ISO 9001:2015 QMS, and Kosher.