NCRAF - Lessons Learned: Effective Inspection Readiness Program

Speaker: Carmen Amador, Chief Quality Officer, The LaSalle Group

Regulatory inspections are crucial to maintaining compliance within regulated industries, especially in the life sciences industry. Given the high stakes of these inspections, organizations must remain compliant. Through her presentation, Carmen Amador will share lessons learned, common pitfalls, and the importance of inspection readiness to ensure the organization is always inspection-ready. Her strong background and over 40 years of experience in the regulated industry allow her to provide key insights about developing a structured approach and skilled resources will yield in maintaining the state of compliance.

Speaker biography

Carmen Amador, BS, is a seasoned Quality and Regulatory Affairs executive with over 35 years of experience in the pharmaceutical, biologics, and bulk-chemical industries, managing multi-national facilities for manufacturing and distributing prescription, OTC products and medical devices. This includes the Quality Operations management of three large manufacturing facilities with a solid record of growth expansions, regulatory compliance, outstanding partnership with FDA & WW regulatory agencies, site validations and start-up of various new facilities and expansions ranging from 250M to 750M, and the transfer, scale-up and launch of over 150 new products and line extensions. 

Carmen possesses in-depth knowledge of pharmaceutical technologies and their applicable domestic and international regulations, including chemical sterile plants, solids, semi-solids, liquids, injectables, lyophilized products, isolation technology, small molecules, large molecules (biologics), and clinical diagnostic products. She has demonstrated a proven track record of strategic resource partnering and organizational transformation, leading successful teams in Latin America and European countries. He is driven by a commitment to continuous improvement, developing and enhancing processes, systems, and workforce development necessary to thrive in a highly competitive environment. In addition, Carmen is proficient in both English and Spanish.

BA in Science Majoring Biology and Minor in Chemistry, University of Puerto Rico 

• Outstanding track record of regulatory approvals for new products, 500+ approvals, as well as pre-approval inspections for NDA and BLA submissions.
• Regulatory Compliance Achievements include best practices in WW Regulatory Strategy, Compliance and submissions, Quality Systems, LEAN Six Sigma Methods, QRM, Manufacturing Quality Management, Inspection Readiness, New Product Introduction and Project Management, Quality Culture Transformation, and Lean Labs.