Melita Ball is a Regulatory & Quality Systems professional with 28 years' experience in Life Sciences. She is the CEO and Principal Consultant at MBC & Affiliates, Inc. (MBCA). She has particular expertise in establishing compliant quality systems and leading large and small teams on remediation projects. Melita is considered an expert in global regulatory compliance requirements including: ISO 13485:2016, ISO 14971:2012, PMDA MO 169, BGMP 16/2013, TGA Therapeutic Goods (Medical Device) Regulations 2002, EU 2017/745 (New MDR), 21 CFR Parts 11, 801, 803, 806, 809, 810, 820, and MDSAP. She is a recognized expert in providing consulting services for life science companies in the areas of Internal & Supplier Quality System Auditing, FDA 483 and Warning Letter mitigation, GxP Training, Medical Device Auditor Training, Purchasing & Supplier Controls, Software Validation (including electronic records & electronic signatures), Business Process Re-engineering, Design Controls, Management Controls, Complaint Handling systems, CAPA, Document Controls, Record Controls, and Change Controls. Melita is experienced in establishing and leading consulting teams through large projects to achieve successful outcomes for her clients.