As an Associate Partner in L2 Consulting, Creliza (Crel) Sobrepena has over 18 years of experience in quality assurance and compliance activities obtained from contract research and the medical device industry. She has covered a wide range of regulatory requirements and best-practices across international GXPs, medical device/pharmaceutical regulations, guidance documents, as well as ISO 9001 and ISO 13485. She has been pivotal in establishing or improving the qualitymanagement systems of multiple companies to ensure regulatory compliance and inspection readiness. Her hands-on experience in quality system components including but not limited to internal and external audits, document control, change management, equipment qualification, method/process/computer systems validation, supplier/subcontractor management, risk management, process monitoring/performance metrics and deviation/nonconformance management enable her to provide invaluable input on gap assessment, continuous improvement and training activities.
Crel is a highly experienced and credentialed QA professional.
Creliza Sobrepena BSc, RQAP GLP