Quality Lean Solutions

Quality Lean Solutions Quality, Regulatory and Manufacturing Consulting Services

12/07/2025

ASQ New England Discussion Group (NEDG) Presents
by request:

VIRTUAL WEBINAR:
“QMS CURRENT REGULATORY REQUIREMENTS- Part 3”

Taming Complaints, Conducting Global Adverse Events
Reporting , and Mastering CAPA Compliance
December 9, 2025, 4:00-7:00 PM ET

Are Your Quality Practices Aligned with Today’s Regulatory Expectations?

With evolving QSR, QMSR, and ISO 13485 standards, ensuring your systems are compliant is more critical than ever.

Join us for an in-depth “How to Comply” webinar designed to give you the practical knowledge and tools you need to stay fully compliant with current regulatory requirements.

KEY SESSION TOPICS
• Efficient Handling of Complaints
• Managing Global Adverse Event Reporting
• Conducting Successful CAPA Investigations

WHAT YOU WILL GAIN
• Master current practices for complaint handling, adverse event reporting, and CAPA management.
• Learn directly from industry experts with hands-on regulatory experience.
• Avoid common pitfalls when implementing or improving your quality systems.
• Deepen your understanding of CAPA—from root cause analysis and action planning to verification of effectiveness and preventive actions.
• Stay ahead of change with an expert review of the FDA’s latest QSR updates to complaint management.
• Go beyond the typical (US, EU) - what does my company need for global AE reporting with Australia, Canada, China, Japan, Brazil, others?
• Dive into and understand the GHTF’s Post Market Global Guidance
• Learn from India’s Comparative Study of various country adverse event reporting.
To ensure your organization is audit-ready and aligned with the latest global quality expectations- Reserve your spot today and take control of compliance!

05/20/2024

Risk-Based Supplier Quality Management
ASQ NEDG is presenting an event on Risk-Based Supplier Quality Management on May 23, 2024, from 3:30 PM - 8:00 PM EST for $179.00.

Join our expert presenters to learn how to reduce supplier risk and make your Supplier Quality Management Process risk-controlled, efficient, and meeting regulatory requirements. Discover how to mitigate quality risk throughout your supply chain and handle "off-the-shelf components". Register now to understand how to make your existing supplier quality practices functional and compliant.

From our family to yours - happy thanksgivingWinston the wonder dog
11/23/2022

From our family to yours - happy thanksgiving

Winston the wonder dog

ASQ Certified Medical Device Auditor (CMDA) Certification Prep classNovember 9-11 (3 days), 8:30AM - 5PMHilton Boston Lo...
10/11/2022

ASQ Certified Medical Device Auditor (CMDA) Certification Prep class
November 9-11 (3 days), 8:30AM - 5PM
Hilton Boston Logan Airport
One Hotel Drive, Boston, MA 02128

This Certified Medical Device Auditor (CMDA) refresher training is a 24-contact hour review delivered over three days. It is designed and taught to help experienced auditors prepare for the CMDA exam. It is intended to help the learner become thoroughly familiar with the complete Body of Knowledge (BoK) by understanding the content covered by the four main domains in the ASQ CMDA BoK.

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10/11/2022
Consider this - how would you like to still make a difference even after you pass away? Becoming an organ donor is easy ...
03/20/2022

Consider this - how would you like to still make a difference even after you pass away? Becoming an organ donor is easy and you are saving the lives of loved ones. The way they respect the donors was simply beautiful!
I love inspecting great companies like Lifeline of Ohio. Great people doing a great job!

After five consecutive years, I was going to stop doing these rucks.  However, Winston the Wonder Dog called me out and ...
02/05/2022

After five consecutive years, I was going to stop doing these rucks. However, Winston the Wonder Dog called me out and said I was acting like a "whiny little b*tch," so we're signed up again....
Your tax deductible donations go to help the families of the fallen, who have provided you the freedom you enjoy every day.
Therefore, I encourage you to support anyone that is putting themselves out for this event.
thank you for your support - Gunny and Winston the Wonder Dog

I AM TOUGH RUCKING FOR AMERICA'S FALLEN MILITARY & FIRST RESPONDERS This APRIL, I will be joining Tough Ruck Nation to complete a marathon with a 35lbs rucksack (backpack). Tough Ruck 26.2 Boston is an elite group of 1000 who ruck to HONOR AMERICA'S FALLEN MILITARY & FIRST RESPONDERS...

My office view today…what’s yours look like?
12/14/2021

My office view today…what’s yours look like?

Travel can be hard, and not always the best - bad service, full flights, delays AND rude people!Best thing I did for mys...
12/09/2021

Travel can be hard, and not always the best - bad service, full flights, delays AND rude people!
Best thing I did for myself was to signup for the Amex credit card - access to the lounges and food. Nothing wrong with making life a little easier when you’re a road warrior!

When your Mentor and good friend come to town- of course you take them out for dinner!Mark Durivage is just awesome and ...
12/08/2021

When your Mentor and good friend come to town- of course you take them out for dinner!
Mark Durivage is just awesome and he’s a big WWII fan so it was appropriate to give him my signed book.

Happy Hanukkah 🕎
11/28/2021

Happy Hanukkah 🕎

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Northborough, MA

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