Welcome to G3QARA Auditing and Consulting Group

Over 35 Years of Excellence!

About Us

Our Services

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35 Yrs of industry experience currently utilized as Acting VP/Director of QA/RA/ Development/Engineering/HR/Compliance Auditor/483 Remediation Project Manager as needed; Also have Document control, auditing and engineering resources as needed.
Regulatory
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. 

Our Projects

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Our projects are your projects - let us know what you need help with and we will partner with you for success



STUDENT FORUMS

The Echelon Leadership Academy 2018 

will be held June 4 through August 4 2018 

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...

8a.m. - 2p.m. Monday through Thursday

at 

The UpLift Center

1555 S Gilbert Rd Suite 100

Mesa AZ  85204


Junior High

High School

College Freshman 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


Registration and eligibility interview scheduling is OPEN now through May 30th 


HOW TO REGISTER???

For more information, scholarship details and registration forms contact 

Krystylle 480-227-9743 

or email her at 

g3qara@gmail.com


Pay $200 Registration Online








Pay Weekly Fee Online



Recommendations

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"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

“I had the distinct pleasure of being the HR Business Partner supporting Krystylle and her Quality team in GE Healthcare for Life Sciences in Arizona. Besides being an awesome leader, Krystylle's quality acumen and knowledge of FDA and ISO regulations helped to build a solid foundation for all the businesses she supported. If I owned a manufacturing establishment, I would consider hiring her company to provide auditing, training and consulting in QARA, Project Management.”

Anissa Zabriskie Human Resources Manager , General Electric Healthcare

“Krystylle epitomizes what a good QA professional can bring to an organization. A great colleague, manager, and team player who is able to resolve conflict, lead initiatives, and drive change. A mentor to her team Krystylle was well respected not only by her direct reports but also by her colleagues as well as upper management. Actively taking part in numerous projects that identified, resolved, and then monitored critical quality programs that reduced waste and improved efficiencies. Krystylle is an astute, dedicated quality professional who understands the complex systems that drive improvement in the ever-changing world of ISO, GMP, and medical device. Krystylle would be an invaluable asset to any new business start-up or established organization.”

Greg Marini Medical Device Engineer, Bivona Medical Technologies

“Krystylle Richardson is an expert and conscientious quality professional. Krystylle uses her knowledge of quality regulations and business process to design quality systems that enhance business performance. I recommend Krystylle to any organization that requires a robust quality system to support the business.”

Bill Daly Operations/MFG Director, Amersham Biosciences/Amersham Pharmacia Biotech

“As a Senior Scientist and Project Manager at Motorola Life Sciences I was responsible for facilitating the launch of new products, developing quality control tests for raw materials, and accessing the suitability of vendor chemistries for a DNA-based diagnostics start-up. I interacted daily with Krystylle Richardson, the head of Quality Operations, who was charged with building a Quality infrastructure from the ground up. In that capacity I knew her as a successful project manager, product validation chair, lead auditor, and quality trainer. Krystylle is a dedicated professional, a pleasure to work with, and I give her my highest recommendation.”

Dennis Carlton Senor Staff Chemist, Motorola Life Sciences

“I have had the pleasure of working with and knowing Krystylle for over 10-years and in a word to describe her work performance, work ethic, and dedication, all I can say is simply.......BRILLIANT! She can succeed at anything she desires; she is a Rock Star!! and possesses a wonderful attitude. She is an awesome manager, very personable, and drives hard for project completion. Her practical knowledge of quality assurance and regulatory affairs is certainly among the best I've ever encountered and I would strongly recommend Krystylle for any personal/professional endeavor she seeks!”

Tom Myers Quality Engineer and Document Control Supervisor, Bivona Medical Technologies

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Questions & Estimates

Please reach out at your convenience so we  can discuss your project.  

G3QARA Auditing and Consulting Group

(480) 227-9743

Hours

Monday - Friday: 8am - 5pm

Saturday - Sunday: Closed