Marian Boardley

About Marian Boardley

I build regulatory software for the dietary supplement, food, and drug industries…

Experience

1. Principal Consultant

   Marian Boardley Consulting Llc

   Apr 2008 — Present · Moab, UT, US

   Consultant to clients in the dietary supplement, food, and drug industries in good manufacturing practices (cGMPs). Conduct audits for compliance with regulatory requirements for manufacturing Establish procedures and policies for all aspects of manufacturing and quality assurance operations. Assess internal and contract laboratories for compliance with cGMPs and FDA guidance for product testing, and provide expertise on identity requirements for dietary ingredients, raw materials, and selection of lab instrumentation. Speak at conferences, seminars and industry meetings, and train staff on cGMPs and laboratory compliance. Implement compliant strategies for botanical ingredients and identity testing. Write SOPs, specifications, Master and Batch records, and other documentation required by 21 CFR Part or 21 CFR Part 211 Regularly train personnel to be ready for FDA inspections and be familiar with current GMPs Devise testing strategies for raw materials, in-process, and finished product testing Perform on-site and third party GMP and analytical laboratory audits Review dietary supplement labeling

Skills

• Cgmp Practices
• Oracle Sql
• Oracle Applications
• Mysql
• Nutraceuticals
• Food Quality
• Analytical Chemistry
• Ftir
• Hptlc
• Microsoft Excel
• Microsoft Office
• Regulatory Affairs
• 21 Cfr Part 11
• 21 Cfr 111
• 21 Cfr 211
• Food Labelling
• Quality Management
• Natural Products
• Public Speaking
• Training
• Gmp
• Quality System
• Fda
• Hplc
• Chromatography
• Regulatory Requirements
• Software Documentation
• Sop
• Quality Assurance
• Laboratory
• Ingredients