Experience & Expertise

Our Team Melita Ball, Principal Consultant, Owner Ms. Ball is a Regulatory & Quality Systems professional with over 19 years of experience in Life Science Quality Assurance and Regulatory Compliance. She has particular expertise in establishing compliant quality systems based on ISO 13485:2003, ISO 14971:2007, and 21 CFR Parts 11, 801, 803, 806, 809, 810, 812, and 820. She is a recognized expert in providing consulting services for life science companies in the areas of GxP training, auditing, software validation (including electronic records & electronic signatures), business process re-engineering, complaint handling systems, and effective document and change control deployment. Ms. Ball is certified by the American Society for Quality (ASQ) as a Certified Quality Auditor (CQA). Our Accredited Team of Specialists RAC-certified Regulatory Affairs Associate – Writes, delivers, and defends new product submissions Sterilization Engineer Associate – Conducts EO & Gamma sterilization validations, re-validations, contract sterilizer monitoring and auditing Bio-Statistician Associate – Provides statistical analysis and biostatistics support; creates and delivers customized or basic biostatistics courses and delivers them at the client site Molecular Diagnostic Scientist & Clinical Database Associate – Creates validated databases to support scientific and clinical studies ASQ certified Quality System Lead Auditors – Conduct audits for ISO 9001; ISO 13485:2003; 21 CFR Part 820; 21 CFR Parts 210 & 211; 21 CFR Part 11; MDD; CMDR; and MHLW (JPAL) From the Manufacturing Floor to the CEO Principal Consultant Melita Ball's expertise is derived from working in every capacity of Quality Assurance and Regulatory Compliance. Beginning as a manufacturing floor operator, she quickly became a Quality Manager and then progressed to Director of Quality Assurance and Regulatory Compliance at Third Wave Technologies prior to launching her consulting business. Ms. Ball has also held senior positions in compliance and training, including Manager of Regulatory Compliance at Ventana Medical Systems; and Senior Manager of Corporate Quality System Training & Documentation at ALARIS Medical Systems. Melita Ball - Curriculum Vitae (PDF)

Our Model for Success Long term relationships with clients Consistent, practical advice that works for the client’s business Ability to successfully lead organizations out of trouble with the FDA (FDA warning letter mitigation) Experience Across the Globe MBC & Associates has worked with clients across the globe, including Malaysia, Asia, Europe, Canada and throughout the United States. A Business Approach Companies often struggle with how to comply with regulations while operating an efficient business practice. The two are not in conflict but dependent upon the other. Finding this balance brings the following benefits to the company: More effective processes More efficient processes Increased product quality Decreased scrap over time Eliminate recurring manufacturing & supplier problems by focusing on root causes Faster throughput