ABOUT

Minnesota Quality (MNQ) Consulting Services
 

MNQ Consulting Services focusses on helping small to mid-sized companies to:

  • Set up quality and regulatory systems for Food, Pharmaceutical and Medical Device industries to comply with ICH and FDA regulations;

  • Perform supplier and internal audits for standards such as ISO 13485, ISO 17025 and regulations such as, 21 CFR 210, 211, 820;

  • Support clinical quality system set up and audit;

  • Troubleshoot Quality issues for CAPA and Out of Spec laboratory test results;

  • Provide on-site and web based training on quality, regulatory and testing related topics to support the medical device and pharmaceutical industries globally; and 

  • Support and document method development and validation for your regulatory compliance

 

Bio
Meena Chettiar, CEO, Principal

Meena@mnqconsulting.com

Phone: 612-747-9635

Founder and lead consultant of MNQ Consulting Services, Meena Chettiar has over 25 years of experience working in Quality and Compliance for Health Canada, big medium and small scale FDA regulated Food, Pharma and Medical device industries in the United States. Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices and Post graduate certification in Applied Clinical Research from St. Cloud State University, Minnesota, USA, Chemical engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Meena is an Exemplar Global Certified Principal Auditor with over 20 years of auditing experience in pharmaceutical and medical device industries in the US and countries like India, Canada, Costa Rica and Puerto Rico.

 

Meena has played key roles (from bench scale to senior management) in quality system implementations and maintenance in global  food companies such as Land O’Lakes, pharmaceutical companies such as Teva Pharmaceuticals, and medical device companies such as Baxter, Covidien and ProMed for over 15 years in the United States. Meena has worked for Health Canada and Agriculture Canada for about 10 years in various technical capacities. Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US and abroad for Pharmaceutical API, Excipients and medical device suppliers including testing and sterilization service suppliers. Meena has represented her companies in several FDA and several global regulatory audits Meena is a senior member of ASQ (American Society for Quality) and is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence).She has served as an instructor for these ASQ certification classes since 2006 and as an adjunct instructor for Medical Technology Quality Graduate Program at St. Cloud State University since 2013 Meena  presents webinars for international companies on “ current” topics related to quality and compliance for FDA regulated industries.

 

Meena is the co-author of Indiana Primer for Certified BioMedical auditor hand book and has authored a chapter for ASQ Supplier Handbook in addition to serving as a certified instructor for ASQ Training Institute for bio medical audit certification. To recognize Meena’s passion to contribute to Science and Technology, MFEST (Minnesota Federation of Engineering, Science and Technology) nominated her as the distinguished science and technology professional for 2015. As a senior Member of ASQ ( American Society for Quality) Meena has served as a subject matter expert  for ASQ’s professional exam development process. Meena has volunteered for Minnesota section of ASQ for about 15 years and will serve as the Chair for 2017.

After serving successfully in the private and government sectors for over three decades, Meena is looking forward to taking up short and long term challenging assignments as a consultant for MNQ Consulting to help troubleshoot, set up, maintain, audit  and offer training in quality systems for regulated industries to support QC, QA and RA. .

Fulfilling customer needs by meeting your regulatory and quality requirements through honest, hard work, timely delivery with superior value and attention to details is the MNQ Consulting Mission.

Our vision is to play a role in introduction and improvement of FDA regulated products to the global public to improve the quality of life for every human being today and for years to come.

 

© 2016 by MNQ Consulting Services LLC

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