(480) 227-9743

G3QARA Auditing and Consulting Group, Inc.

G3QARA Auditing and Consulting Group, Inc.G3QARA Auditing and Consulting Group, Inc.G3QARA Auditing and Consulting Group, Inc.

G3QARA Auditing and Consulting Group, Inc.

G3QARA Auditing and Consulting Group, Inc.G3QARA Auditing and Consulting Group, Inc.G3QARA Auditing and Consulting Group, Inc.
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(480) 227-9743

  • Home
  • About G3QARA
  • Contact Us
  • Services and Merchandise

Inventors, C-Suite & Company's Welcome to Consulting with Krystylle & Team

Inventors, C-Suite & Company's Welcome to Consulting with Krystylle & TeamInventors, C-Suite & Company's Welcome to Consulting with Krystylle & TeamInventors, C-Suite & Company's Welcome to Consulting with Krystylle & Team

Over 40 Years of Excellence!

Contact Us

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    About Us

    Our Services

    C-Suite, Teams, Students...

    C-Suite, Teams, Students...


    40 Years in Operations

    with 35 Years as a C-Suite Exec
     

    Keynote Speaker for your C-Suite Summit & Teaming Session, Invention Help, 

    Innovation Roadmaps&Audits, Software&Process Validation Maps 

    C-Suite Coaching, Operational Excellence, InnovativeThinking 


    Regulatory
    Invention Pre-Development Documentation, Regulatory consultation on U.S. 510


    40 Years in Operations

    with 35 Years as a C-Suite Exec
     

    Keynote Speaker for your C-Suite Summit & Teaming Session, Invention Help, 

    Innovation Roadmaps&Audits, Software&Process Validation Maps 

    C-Suite Coaching, Operational Excellence, InnovativeThinking 


    Regulatory
    Invention Pre-Development Documentation, Regulatory consultation on U.S. 510(k) preparation and clinical trials set up
    General training on requirements for U.S. PMA (Pre-Market Approval) application
    Regulatory consultation on the CE Marking process, Authorized European Representative agreements, Technical Dossier creation, training on regulatory requirements
    Regulatory planning - Services relate to plan creation and or assessment of a company's regulatory plan as a part of due diligence activities for acquisition or investment reviews

    Auditing
    Comprehensive Due Diligence Audits for acquisition assessments
    Audits and QMS set up for ISO 9001:2008; ISO 9001:2015
    Audits and QMS set up for ISO 13485:2003, ISO13485:2016
    Assess compliance to 21 CFR Part 820, 801, 803, 606 and 11
    Intro training and audits per the Medical Device Directives
    Internal Auditing - training, audit as an ongoing contract internal auditor (annually) or one-time audit
    Clinical Trials and CRO [CLIA Laboratory] Audits How to plan for a Notified Body audit - gap assessments and Do's and Don'ts
    How to plan for an inspection by the FDA - Do's and Don'ts and gap assessments

    Operations and Engineering
    Facilities Start Up and/or Transfer - Facilities Qualification
    Process/Software Validation Master Planning/Execution (FAT, SAT, IQ, OQ, PQ)
    The pragmatic use of Six Sigma Tools and Techniques; Kiazen and 5S training and deployment (managing the workplace[gemba], waste elimination [muda], standardization)
    Design for manufacturability and design transfers
    Quality engineering for design, manufacturing, molding, extrusion and automation (including Cost of Quality, FMEA, DOE, Cpk studies, SPC implementation, value stream mapping, process flows, gage R&R;, MSE, 5M, 8D and more)
    Project Management - training and or assessment
    Business Continuity Planning, audits and testing of the process

    Human Resources
    Resource and skill set assessments for organizational realignment and operational excellence
    Think Global - A program designed to enlighten participants on valuable tips, things to think about and implement before working outside of the U.S.
    Contact us today for a quote that can be customized to your specific compliance partnership need. 

    C-Suite, Teams, Students...

    C-Suite, Teams, Students...

    C-Suite, Teams, Students...


    Success is defined various ways.

    We evaluate what you want, help you outline what you need to get there and catapult you into execution and success-mode.


    Our projects are your projects - let us know what you need help with and we will partner with you for success in business, as an inventor and much more.


    BUSINESSES THAT NEED TO 

    GET BACK ON 


    Success is defined various ways.

    We evaluate what you want, help you outline what you need to get there and catapult you into execution and success-mode.


    Our projects are your projects - let us know what you need help with and we will partner with you for success in business, as an inventor and much more.


    BUSINESSES THAT NEED TO 

    GET BACK ON TRACK


    ADULTS IN BUSINESS 

    NEW BUSINESS START UPS


    STUDENT FORUMS

    The Echelon Leadership Academy 

    ASK ABOUT GROUP AND INDIVIDUAL LEADERSHIP TRAINING FOR YOUR YOUTH/YOUNG ADULT 


    Jr Echelon Ages 8-12

    Sr Echelon Ages 13-17

    Echelon Elite Ages 18-22


    With Educational and Fun Initiatives 

    S.T.E.M. Engineering 

    Business Management

    Criminology

    Six Sigma

    Situational Leadership

    Fundraisers

    Community Service

    Officer Elections to run their Camp Business and learn how to be a young Entrepreneur

    Engage with Fortune 500 Companies

    & More...

    The UpLift Center

    1555 S Gilbert Rd Suite 107

    Mesa AZ  85204


    Eligible ages

    Elementary School 

    Junior High

    High School

    College Divisions


    The Top 3 Benefits of joining the Echelon Leadership Academy:


    1. Catapulting Experience 

    Your student will gain that edge that will make him or her a better candidate for the jobs they seek in the corporate world


    2. Acceleration 

    Your student will be exposed to various careers and skillsets crucial to success in domestic and global positions


    3. Leadership 

    Your student will have a greater understanding of how teamwork propels them into a successful career as a leader and sets them apart in the workforce


    HOW TO REGISTER???

    For more information, scholarship details and registration forms contact 

    Krystylle 480-227-9743 

    or email her at 

    g3qara@gmail.com



    Recommendations

    C-Suite, Teams, Students...

    Recommendations


    "Krystylle has done a wonderful job directing QARA at GMSbiotech and also as de facto head of Development as we await hiring a VP of Development. She has a deep knowledge of FDA related matters and the overall development process." 

    Mike Hogan CSO at GMS Biotech


    "Krystylle is a true expert in the Quality & Regulatory field. She has provided


    "Krystylle has done a wonderful job directing QARA at GMSbiotech and also as de facto head of Development as we await hiring a VP of Development. She has a deep knowledge of FDA related matters and the overall development process." 

    Mike Hogan CSO at GMS Biotech


    "Krystylle is a true expert in the Quality & Regulatory field. She has provided the leadership to support the implementation and ongoing improvement of our quality systems, leading to successful ISO 9001 & 13485 certification. She is an excellent communicator with all levels of the organization, with customers, and with external auditors. I strongly recommend consideration of Krystylle and her company G3 Quality and Regulatory Auditing and Consulting." 

    Alastair Malcolm CEO, Applied Microarrays Inc


    “I worked with Krystylle for four years at Motorola Biochip Systems/Life Sciences as Director of Chemistry and R&D.; R&D; in general is notoriously difficult to convert to the idea of a quality system. Krystylle, through a combination of well-thought out application of QA to R&D; needs, considerable skill, and the force of her delightful personality, convinced the skeptics. She is an excellent leader for QA, because she not only implements the system, but makes it work by getting people to buy into the idea. She is also an excellent auditor, attuned to details, but not focused on trivialities. She sees the overall picture and the role quality must play in it. I would hire Krystylle as an auditor, consultant, or a full time quality director without any hesitation. I recommend her most highly.” 

    Chuck Brush Dir R&D; , Motorola Life Sciences


    Krystylle Richardson, President of G3 Quality & Regulatory Auditing & Consulting Group, has been invaluable as a MedApps' consultant. Krystylle completed an internal ISO 13485/MDD audit of our Quality Management System, performed two supplier audits, and provided guidance on quality/regulatory questions. With her support and experience, MedApps received ISO 13485, ISO 9001, & MDD certifications during our first registration audit. MedApps would not have been able to have the QMS success without her assistance.” 

    Bobbi Sanchez (client) Top qualities: Great Results, Expert, High Integrity


    “I had the pleasure of working with Krystylle at Amersham/GE healthcare Codelink operations. As Director of Quality, Krystylle's enthusiasm, teamwork, talent and professionalism created an outstanding quality culture within the Codelink organization. I would highly recommend Krystylle for your quality systems needs.” 

    Peter Kahn Director Systems Engineering, GE Healthcare


     HOW TO BOOK KRYSTYLLE OR HER TEAM???

    For more information, contact 


    Krystylle 480-227-9743 


    or email her at 


    g3qara@gmail.com

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    G3QARA Auditing and Consulting Group

    (480) 227-9743

    Hours

    Monday - Friday: 8am - 5pm

    Saturday - Sunday: Closed

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