Office Hours at UCSF Rosenman Institute

Posted on: October 23, 2019

Nicolle Cannon, Cannon Quality Group

Are you unsure about when to introduce a quality management system for your early-stage venture? Perhaps the step seems daunting and you’re putting it off? Apply to meet with Nicolle Cannon of the Cannon Quality Group for a 45-minute slot the afternoon of Thursday, November 21. CQG specializes in developing right-sized quality systems based on product risk/class, organization size, organizational stage, with an eye toward being “strategic partner friendly”.

Our office hours are hosted by leading experts who have generously offered their services pro bono to our entrepreneurs.

If you choose a timeslot, we will require a $100 credit card deposit. The deposit will be refunded the day after you attend. No-shows will not receive a refund. Please be punctual; arrivals late by more than 15 minutes will be considered no-shows.

If you find that you are unable to attend, you may request a refund up to 5 days in advance. (This will give us time to offer the slot to the first person on the waitlist.) We regret that we cannot honor requests made at a later time.

Where & When
Suite 214, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Thursday, November 21, 2019

Applications open thru Friday, November 8.
https://innovatorsummits.smapply.org/prog/office_hours_with_nicolle_cannon_-_november_21/

About Nicolle Cannon

Nicolle Cannon, Founder of Cannon Quality Group, is celebrating her 10th year of growing an engineer-minded Quality Assurance professional support organization. The team at CQG are focused on helping organizations take the fear out of quality and implementing smarter quality management systems that add value to the business.

Nicolle’s journey started when she graduated from California Polytechnic State University where she received her Bachelor of Science in Mechanical Engineering. From there, her career began as a Quality Engineer, working and learning through different engineering and leadership roles until she became Senior Director of Quality for a large public medical device company.

It was during her work as an engineer in medical device companies where she grew frustrated with quality systems and quality organizations that were built on fear of the regulation. Through the years, Nicolle has observed quality organizations that continue to build quality systems that are based on fear of the standards and regulations. Her frustration mounted as she watched great products, that could be helping patients, stagnate in systems that did not aid in innovation.

Nicolle founded Cannon Quality Group, LLC in 2009 with the primary focus of aiding new safe technologies into the clinic fast so they can help improve the lives of patients. She believes that quality systems are a world of GREY, and in order to implement an effective quality system into an organization, you need to factor in product class/risk, organization size and organizational stage.
Her ideas are that there is not a one-size-fits-all solution to the quality system need, and that it is paramount to the success of the organization to implement a right-sized quality system approach.

Cannon Quality Group’s specialties are working with organizations of any size, from startup to public, including manufacturers and suppliers, providing assistance and leadership in implementing and maintaining Quality System solutions.

Testimonials

"I just wanted to drop a quick note to thank you all for your support over these past several months. We had a very successful audit this week. Both auditors were very complimentary of the progress we have made since the last audit and that is really a testament to…"

-Zachary Woodson/Vice President of Regulatory Affairs & Quality, LimFlow SA

"Look what you have done!  Profusa has a functional QS thanks in large part to you. The GMED auditor has conducted over 700 audits and said we have an extremely good QS and a lot of that credit goes to you… I just wanted to let you know that Profusa…"

-David Hesting/QA Director, Profusa, Inc.

"My Manager reviewed and approved this validation, and he called me to say it would be the gold standard for spreadsheet validations for all Nordson Medical D&D sites from this point forward!"

-Kim Trottier/Quality Information Systems Manager, Nordson Medical

"Our notified body commented that he was impressed with the focus and professionalism of the Emboline team during a recent audit. This is largely a credit to the Cannon Quality Group team. Your team, as always, was extremely organized, well-prepared and professional. Thank you!"

-Scott Russell/President and CEO at Emboline, Inc.

"Everything about the audit process including scheduling, the audit itself, and results & follow-up were seamless and enabled LamaMed Solutions, Inc. to fulfill its requirements for Internal Audit and assessment of QMS conformance with ISO 13485:2016 in advance of our Notified Body audit."

-Lloyd Griese/Quality and Regulatory Consultant, LamaMed Solutions, Inc.

"Our SVP of QA/RA performs mock-FDA audits across all our global facilities. So it was huge compliment for us when, after reviewing all aspects of a software validation authored by Cannon Quality Group, he said it was as good a validation as he had ever seen."

-Ron Koronkowski/Director of Quality & Regulatory, Vention Medical, Inc.

"Cannon Quality Group's staff was highly engaged and responsive to our needs. They were easy to work with and provided a high-quality work product."

-Caroline Jewett/Consultant for PvP Biotech

"It was by far the best QSR/GMP training – high caliber content and engaging delivery."

-Robert Angelopoulos/Sr. Engineering Manager, Powervision, Inc.

"Don’t stress. Call Cannon Quality Group for great project support."

-David Freed/Sr. Quality Director, AcelRx Pharmaceuticals, Inc.

"My 3rd party ISO 13485:2016 audit was extremely beneficial to my company. The auditor was very knowledgeable about the standard and current trends that notified bodies are looking for."

-Tom Mason/Director QA, Vactronix Scientific

"When strategic partners were doing due diligence, I think they expected to find an empty drawer where the Quality Management System would be. We started showing them the procedures and design files that Cannon Quality Group helped us establish, and they were pleasantly surprised to get just what they wanted…The ability of…"

-Don Bogue/President/CEO, Compact Imaging

"Our [CQG] auditor provided findings with value-based explanations and implementation ideas."

-Kyle Dion/Quality Specialist, BlueLine Sterilization Services

"CQG has been with my organization from the nascent stages of our QMS.  Their team of experts coached us on the ISO standards, provided training classes, furnished sample QMS documentation, and were always quick to respond to our endless questions.  Most importantly they were present at our crucial certification and customer audits. …"

-Kathleen Perry/Twist Biosciences

"Working with Cannon was a pleasure. They helped us create our first formalized Quality Management System with just the right balance of rigor, detail-orientation, and practicality. I would definitely work with Cannon again in the future on quality management projects."

-Gideon Wald/CTO Welkin Health

"JenaValve would like to extend a very appreciated “Thank You” to the whole Cannon Group team in supporting us, JenaValve, through the quality system improvements and associated activities. Your organization has been exceptional in supporting the chaotic schedule and the Cannon Group team members have performed above and beyond the…"

-Peter Wulff/CFO JenaValve

"Your team is great, love the maturity level. Great respect from Quality & Regulatory."

-Mark Adler/Senior Director of R&D JenaValve

"CQG has really shattered my preconceptions of what contracted support can do for a quality system. They are true professionals from the advice they provide, work they produce, and the integrity of actions. From complicated design control issues, to Process Validation, to Doc Control, they have been a huge resource…"

-David Hesting/QA Director, Profusa, Inc.

"Amy has done an amazing job here and we appreciate all her help. Communication with everyone/doc control is good/responsive, and we especially appreciate the quick turnaround on hot DCO’s – they find everything."

-Bijesh Chandran/VP of Quality, R2 Dermatology

"Cannon Quality Group is an absolute pleasure. For our startup, CQG made QSR development and compliance enjoyable and easy. Their unique style and system has allowed us to work at the fast pace required by the market, while still maintaining regulatory compliance."

-Andrew Hosford/Director of Engineering, Gauss Surgical

"Our startup was working with a skeleton quality system and struggling to apply QSR standards, when we brought in the Cannon Quality Group. They overhauled and sharpened our quality system so that it complied with the QSR, in only a few months, which allowed us to have a flawless audit.…"

-CQG client/

"When a key employee quit just as the load on my QA group exploded because of a clinical build, CQG stepped in immediately with the resources we needed to keep us going. I hope nothing like this ever happens to us again but, if it does, I’ll know exactly whom…"

-Ari Zak/Sr. VP, Clinical, Regulatory & Quality and Corporate Counsel, PowerVision

"Prior to CQG, our startup worked with another company which made quality slow, very expensive, and highly frustrating. Comparatively, CQG has been a game changer for our company. They have made QSR development and compliance enjoyable and easy, which has allowed us to work at the fast pace required by…"

-CQG Client/

"Kudos to the Cannon Quality Group for helping us get through our FDA audit with zero 483s and just a few CAPAs.Their expertise in quickly turning our bare bones QMS into a robust system is exactly what was needed."

-Shaun R. Bagai/CEO – RenovoRx, Inc.

"Pete is awesome, I appreciate the help he provides to our team and his assistance in various quality needs."

-Kityee Au-Yeung/Profusa

"As a new Quality Director at a young start-up company, I am happy to leave a recommendation for Cannon Quality Group. Cannon Quality Group has an innovative and efficient process in place to bring a working Quality System to a start-up company in a short amount of time. Cannon retains…"

-Delane Dale/Quality Director – BioInspire Technologies
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