Dan Feddersen Email and Phone Number

External Quality Assurance

▪ Directly managed all quality and compliance for several contract manufacturing organizations (CMOs) focusing on ensuring products are manufactured within both federal/state regulations and company requirements▪ Worked closely with both QA and QP professionals on the oversight of manufacturing for coated tablets, capsules, powders, medical devices, intratracheal suspension, injectable antibiotics, and suppository products▪ Participated in quality audits of all CMOs, maintain positive relationships with internal customers within other departments, and provided QA related expertise in S&OP meetings▪ Analyzed and identified risk factors within manufacturing processes, managed quality systems meetings, and reviewed all master batch records, validation protocols, validation reports, specifications, analytical methods, deviations, OOS reports, and change control records▪ Reviewed and implemented Quality Agreements with CMOs, lead regular quality systems meetings and assured compliance with Quality Agreement requirements▪ Created shipping and thermocycling studies/reports, participated in high-level business meetings, and created best practices for the department

▪ Oversaw all daily operations of internal laboratories and manufacturing quality assurance within a manufacturing site which produced oral/topical liquids and medical devices▪ Acted as Audit Manager for FDA, DEA, internal compliance, and outside vendors which required extensive organizational and record-keeping abilities▪ Implemented all quality systems, oversaw GMP and GLP functions, and managed a diverse team of staff members▪ Designed and created standard operating procedures, validation protocols, calibration protocols, and stability protocols along with providing training to all employees▪ Managed the decommissioning process of a liquid pharmaceutical manufacturing site in addition to the qualification and commissioning of a new packaging facility

▪ Managed quality control related functions within a site which produced oral/topical liquids and medical devices▪ Supervised staff members, ensured consistent adherence to best practices, ensured DEA and FDA compliance, and managed all internal, external and regulatory agency audits