Brittani K.

As a Quality Director with experience in FDA compliance for dietary supplements, cosmetics, and food products, I offer comprehensive expertise in label compliance, specification sheet management, SOP development, and general consulting within the regulatory frameworks of 21 CFR 101, 21 CFR 111, and 21 CFR 117. With a track record of ensuring products meet regulatory standards while optimizing operational efficiency, I am committed to delivering top-tier compliance solutions tailored to the unique needs of each client. Skills: Label Compliance Review: I possess a keen eye for detail when it comes to label compliance, meticulously reviewing dietary supplement, cosmetic, and food product labels to ensure they adhere to FDA regulations. My in-depth knowledge of 21 CFR 101 enables me to identify and rectify any discrepancies, ensuring that clients' products are compliant and market-ready. Specification Sheet Management: I excel in the review and creation of specification sheets for both raw materials and finished goods. By meticulously documenting specifications in accordance with regulatory requirements, I facilitate seamless production processes and supply chain management, minimizing risks and ensuring product integrity. SOP Development: With a focus on quality assurance and regulatory compliance, I specialize in the review and creation of Standard Operating Procedures (SOPs) tailored to the specific needs of dietary supplement, cosmetic, and food product manufacturers. My SOPs are meticulously crafted to streamline processes, enhance quality control, and ensure compliance with 21 CFR 111 and other relevant regulations. Compliance Consulting and Guidance: I provide comprehensive compliance consulting and guidance to clients seeking to navigate the complex landscape of FDA regulations. Whether it's interpreting regulatory requirements, conducting gap analyses, or implementing corrective actions, my expertise in 21 CFR 101, 21 CFR 111, and 21 CFR 117 enables me to provide practical solutions that safeguard clients' interests and uphold industry standards. With a proven track record of success in ensuring regulatory compliance and driving quality excellence, I am committed to empowering businesses to thrive in highly regulated environments. Let's collaborate to elevate your products to the highest standards of quality and compliance.