PLEASE NOTE: the LABEL APP can be found at https://www.labelfactsapp.com/label/
Marian Boardley has been an independent consultant since 2008, assisting over 60 clients in achieving compliance with regulatory standards such as 21 CFR Part 111 for Dietary Supplements. Her services encompass a wide range of solutions, including:
- Dietary supplement cGMP compliance and audits
- Label reviews and mockups for Supplement Facts
- Responding to FDA 483s and Warning Letters
- Developing testing strategies for supplements and ingredients
- Supplier qualification and audits
- Creating SOPs, master manufacturing records, and specifications
- Technical and laboratory documentation
- Quality assurance project management
- Food safety plans and FSMA compliance (PCQI)
Marian's expertise aids manufacturers and distributors in navigating FDA requirements for dietary supplements. She advises on current GMPs, conducts audits, and establishes procedures for quality assurance and manufacturing. Her proficiency extends to identity testing, raw materials, lab instrumentation, and documentation creation. She's also a certified Preventive Controls Qualified Individual under the Food Safety Modernization Act.