Bob Mehta Msqa, Mba, Asq Fellow

Bob Mehta Msqa, Mba, Asq Fellow Email and Phone Number

100+ LinkedIn Recommendations - Providing Consulting and Interim Quality Management Leadership to Devices (SaMD/SiMD), Drugs, Biologic, & Combination Products, FDA's Warning Letter Remediation, & Supplier/Internal Audits @ GMP ISO Expert Services
Bob Mehta Msqa, Mba, Asq Fellow's Location
Orange County, California, United States, United States
Bob Mehta Msqa, Mba, Asq Fellow's Contact Details

Bob Mehta Msqa, Mba, Asq Fellow personal email

About Bob Mehta Msqa, Mba, Asq Fellow

GMP ISO Expert Services (GIES) is a consulting firm specializing in providing industry support for quality/regulatory compliance, quality systems, supplier management, supplier/internal audits, and FDA warning letter/Consent Decree remediation activities for medical device, drug, Combination Product, API, Cosmetic, Aerospace, and Dietary Supplement industries. GIEs has extensive experience to provide quality/compliance leadership to drug, biologic, and device clients as a retainer (VP level).Author of the books: "Implementing ISO/IEC 17025:2017 - A Practical Guide "Practical Process Validation" - available through asq.org or amazon.com"Implementing ISO/IEC 17025:2005 - A Practical Guide ". Book received 4.7 out of 5 stars customer reviews on Amazon.Authored chapters for the book: "The Certified Pharmaceutical GMP Professional Handbook" published in May 2014, used for ASQ CPGP Certification.Industry Board of Advisor - Medical Device Industry Education Consortium (MDIEC)Adjunct Professor - Master of Science Quality Assurance (MSQA) Program - Cal State Dominguez Hills, Carson, CAAdjunct Instructor - Medical Device Certification - ISO 13485:2003/21 CFR 820, North Orange County Community CollegeCareer Chair- ASQ Orange Empire Section 0701Authored articles that were published in Pharmaceutical Technology, Nutraceutical World, Quality Progress and GxP Lifeline publications. Bob regularly publishes articles on a blog on Medical Device and Diagnostic Industry (MD&DI) online.Education: Master of Science in Quality Assurance (MSQA), Master of Business Administration (MBA), B.S. in Chemistry, ASQ certified Quality Auditor (CQA), Six-Sigma Black Belt (CSSBB), Quality Engineer (CQE), Reliability Engineer (CRE), Biomedical Auditor (CBA), Software Quality Engineer (CSQE), HACCP Auditor (CHA), Pharmaceutical GMP Professional (CPGP), ISO 13485:2016 Lead Auditor, ISO 9001:2015 Lead Auditor, and AS9100D Lead Auditor

Bob Mehta Msqa, Mba, Asq Fellow's Current Company Details
GMP ISO Expert Services

Gmp Iso Expert Services

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100+ LinkedIn Recommendations - Providing Consulting and Interim Quality Management Leadership to Devices (SaMD/SiMD), Drugs, Biologic, & Combination Products, FDA's Warning Letter Remediation, & Supplier/Internal Audits
Bob Mehta Msqa, Mba, Asq Fellow Work Experience Details
  • Gmp Iso Expert Services
    Principal Consultant
    Gmp Iso Expert Services Feb 2010 - Present
    GMP ISO Experts are result driven English/Spanish speaking consultants providing the following services to Pharma, API, Medical Device, Dietary Supplement/Food and Cosmetic manufacturers:* Remediation and Compliance Support - English/Spanish Speaking - Respond to FDA's 483s and Warning letters - Respond to ISO 13485/ISO 9001 audit findings - Prepare facility for FDA and ISO inspection/audit - Gap analysis of Quality Systems / MDSAP & assist with remediation - Internal Audits - Validation (equipment, process, test method, software) - Prepare facilities for client/FDA/ISO audits* Audits - Internal and External - Good Manufacturing Practice (GMP) for excipients, Active Pharmaceutical Ingredients (APIs), and finished drug products - QSR and ISO 13485 - US and EU (CE) Marking for Class I, II, and III medical devices. MDSAP and EU MDR 2017/745* Training - MDSAP - GMP/GLP/GCP - ISO 9001:2015 and ISO 13485:2016 - Root Cause Investigation for CAPA - Auditor (internal and supplier audits) - Data Integrity - Risk Management - Validation - Quality Control Laboratory Operations - Minitab - Six Sigma Yellow Belt, Green Belt, Black Belt* Regulatory Submissions - Medical Device and IVD Submissions - 510k, IDE, PMA - Pharma and Biologics - IND, NDA, ANDA, BLA, CTD * Professional Staffing Services (Medical Device, Pharma, Contract Manufacturers) - Contract and Full-time employees for manufacturing, engineering, and quality - Retainer - Confidential Search - Executive Search
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  • Adjunct Faculty Msqa Program - Cal State Dominguez Hills, Ca
    Adjunct Professor
    Adjunct Faculty Msqa Program - Cal State Dominguez Hills, Ca 2010 - Present
    Teach the following courses for Master of Science Quality Assurance program.1. QAS511 - Quality Function Management and TQM2. QAS538 Evaluation and Outcome Analysis for Healthcare Delivery
  • Medical Device Industry Board Of Advisor (Mdiec)
    Industry Board Of Advisor
    Medical Device Industry Board Of Advisor (Mdiec) Apr 2009 - Present
    Medical Device Industry Education Consortium (MDIEC)
  • North Orange County Community College
    Adjunct Instructor
    North Orange County Community College Jan 2009 - Present
  • Asq
    Chairman - Section 0701
    Asq 2008 - Jun 2010
    Milwaukee, Wi, Us
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  • Edwards Lifesciences
    Sr. Regulatory Compliance Manager (Associate Director)
    Edwards Lifesciences Aug 2008 - Feb 2010
    Irvine, Ca, Us
    View
  • University Of California, Riverside
    Adjunct Instructor
    University Of California, Riverside 2010 - 2010
    Riverside, Ca, Us
    View
  • Allergan
    Sr. Worldwide Qa Manager (Associate Director)
    Allergan 2001 - 2008
    Dublin, Coolock, Ie
    View
  • Allergan
    Scientist (Gmp Lab)
    Allergan Oct 1997 - Dec 2001
    Dublin, Coolock, Ie
    View

Bob Mehta Msqa, Mba, Asq Fellow Skills

Quality System Fda Capa Gmp Quality Assurance Validation Iso 13485 Medical Devices Quality Auditing Cross Functional Team Leadership Six Sigma V&v Training Lean Manufacturing Process Improvement Quality Management Continuous Improvement Pharmaceutical Industry Quality Control Supplier Quality Iso Food/dietary Supplements Inspection Manufacturing Remediation Root Cause Analysis Biotechnology Cssgb Asq Change Control Iso 9000 21 Cfr Part 11 Sop Pharmaceutics Lims Testing Business Process Improvement Design Control Iso 14971 Complaint Management Glp Operational Excellence Quality Engineering Validations Clinical Practices Cost Benefits Computer System Validation Good Clinical Practices Fda Pre Approval Inspection

Bob Mehta Msqa, Mba, Asq Fellow Education Details

  • Master Of Science In Quality Assurance (Msqa)
    Master Of Science In Quality Assurance (Msqa)
    Ca
  • American Society For Quality (Asq)
    American Society For Quality (Asq)
    Certified Reliability Engineer
  • Bsi
    Bsi
    Lead Iso 9001:2008/Iso13485 Auditor
  • Uc San Diego
    Uc San Diego
    Good Clinical Practices
  • Asq Certified Biomedical Auditor (Cba)
    Asq Certified Biomedical Auditor (Cba)
    Biomedical Auditor
  • Asq Certified Quality Engineer (Cqe)
    Asq Certified Quality Engineer (Cqe)
  • Asq Certified Software Quality Engineer (Csqe)
    Asq Certified Software Quality Engineer (Csqe)
    Software Quality Engineer
  • University Of Michigan - Stephen M. Ross School Of Business
    University Of Michigan - Stephen M. Ross School Of Business
    Lean Pharma
  • American Society For Quality
    American Society For Quality
    Six-Sigma Black Belt (Cssbb)
  • University Of Michigan
    University Of Michigan
    Lean Pharma
  • Rab
    Rab
    Quality System Auditor (Iso:9001:2000)
  • Caliso
    Caliso
    Iso13485:2003
  • American Society For Quality
    American Society For Quality
    Quality Auditor (Cqa)
  • Pepperdine University
    Pepperdine University
    Business
  • Ahmedabad Science Collegs
    Ahmedabad Science Collegs
    Chemistry

Frequently Asked Questions about Bob Mehta Msqa, Mba, Asq Fellow

What company does Bob Mehta Msqa, Mba, Asq Fellow work for?

Bob Mehta Msqa, Mba, Asq Fellow works for Gmp Iso Expert Services

What is Bob Mehta Msqa, Mba, Asq Fellow's role at the current company?

Bob Mehta Msqa, Mba, Asq Fellow's current role is 100+ LinkedIn Recommendations - Providing Consulting and Interim Quality Management Leadership to Devices (SaMD/SiMD), Drugs, Biologic, & Combination Products, FDA's Warning Letter Remediation, & Supplier/Internal Audits.

What is Bob Mehta Msqa, Mba, Asq Fellow's email address?

Bob Mehta Msqa, Mba, Asq Fellow's email address is bo****@****ail.com

What schools did Bob Mehta Msqa, Mba, Asq Fellow attend?

Bob Mehta Msqa, Mba, Asq Fellow attended Master Of Science In Quality Assurance (Msqa), American Society For Quality (Asq), Bsi, Uc San Diego, Asq Certified Biomedical Auditor (Cba), Asq Certified Quality Engineer (Cqe), Asq Certified Software Quality Engineer (Csqe), University Of Michigan - Stephen M. Ross School Of Business, American Society For Quality, University Of Michigan, Rab, Caliso, American Society For Quality, Pepperdine University, Ahmedabad Science Collegs.

What skills is Bob Mehta Msqa, Mba, Asq Fellow known for?

Bob Mehta Msqa, Mba, Asq Fellow has skills like Quality System, Fda, Capa, Gmp, Quality Assurance, Validation, Iso 13485, Medical Devices, Quality Auditing, Cross Functional Team Leadership, Six Sigma, V&v.

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