Debra Goetchius Email Address

Associate Director, Global Labeling Implementation, Global Labeling Center of Excellence

Janssen Pharmaceutica Products, L.P., is a member of the Johnson & Johnson family of companies, the world's most comprehensive and broadly based manufacturer of health care products. Janssen Pharmaceutica has a long track record in developing and marketing treatments for central nervous system disorders, pain, fungal infections and gastrointestinal conditions. It is based in Titusville, NJ.

Pharmaceutical labeling and packaging graphics professional specializing in labeling compliance, end-to-end artwork management and process development, copy and graphic content quality assurance, change management, project and people management. Passionate about combining the arts and science. Find me at: dbgoetchius@gmail.com or 908.672.5972 Areas of Expertise: Subject Matter Expert on labeling regulatory compliance and FDA/CFR regulations governing product labeling for US human health pharmaceuticals, biologics, vaccines, medical devices, animal health formulations, agricultural products, and bulk pharmaceutical chemicals. Proficient in the design, development, and quality review of text content and packaging graphics for labeling and packaging components used in regulatory filings and print production of US, Canada, and other international drug products. Unique in-depth knowledge of graphic design as it relates to patient safety for container labels and carton labeling to minimize medication selection and dispensing errors. Interpretation of Federal and State regulations; plus, Guidance for Industry for impact on new or established labeling. Extensive interaction and strong collaboration with regulatory groups, including FDA. Quality & Compliance Mindset: Ensures labeling and packaging development is conducted in compliance with regulatory requirements governed by FDA (CDER, CBER, CVM); US Customs; EPA (FIFRA); and Good Manufacturing Practices (GMPs) related to Labeling and Packaging. Key contributor to New Product Launches, including end-to-end process execution. Demonstrated history of building successful collaborative partnerships across functional areas to include: Regulatory Affairs, CMC, Marketing, Package Engineering, Pharmacy Affairs, Pack Sites, Supply Chain and Quality. Demonstrated leadership of cross-functional project teams from design to delivery (end-to-end) of artwork to achieve production readiness-status.