How FDA Evaluates Your Quality Management System – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Live Webinar on Jul 27, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT


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Short Abstract:

QSR imposes many requirements but contain little detail in how to implement them; however, failure to appropriately interpret these requirements could result in significant impact on your company, which may include temporary or permanent removal of your device from the market.

Areas Covered in the Webinar:

  • Introduction to FDA Regulations
  • Overview of Quality System Regulations (“QSR”)
  • How FDA Evaluates Your Quality Management System (“QMS”)
  • Most Inclusive Requirement: Document Control
  • Most Critical FDA Non-conformances
  • Most Common FDA Non-conformances

For More Information Kindly Click here or Copy and Paste Below Link


FDA Software Validation and Verification, Computer System Validation: Step-by-Step – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Live Webinar on Aug 08, 2018 | Available All Day | Duration: 60 Min By: Carolyn Troiano


The FDA (Food and Drug Administration) and IEC (International Electrotechnical Commission) requirements for validation of your manufacturing and quality system software can conjure up a lot of questions. Understanding the actual guidelines and best practices for meeting these requirements isn’t always clear. Your software may be compliant, but you may not be. This webinar provides you answers to the top most Six common software validation and documentation questions asked by the others in FDA regulated industries and express the best practices for meeting the instruction.

The FDA mandates that software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use shall be validated. While ISO (International Organization for Standardization) and SOX (Sarbanes-Oxley) regulations are not as clear about the validation process, they have to need that software development lifecycle processes be followed in areas where they apply because software validation demonstrates evidence which provides a best result of assurance that a specific process will always generate the expected result or output of the given input.

Documentation is required for Regulatory Validation:

  • Software Validation Protocol (Validation Plan)
  • System /Software Requirements Specification
  • Network Diagram
  • Risk Analysis
  • 21 CFR Part 11 Compliance Analysis
  • Verification Protocol (Test Plan)

Session Highlights:

  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • User Requirements Specification (URS) to include high-level needs in language familiar to the user
  • Operational Qualification (OQ)
  • System Acceptance by the user or owner of the system
  • ….. and more



Use “FDA25” to get $25 Off.
Attend in a Group and save upto 50%. Email us at for bulk orders.

Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Live Webinar on May 31, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT | Duration: 60 Min By: Angela Bazigos


Are you contain necessary component or you complete all step of 510(k) submission to allow consume Center resources?

The Office of Device Evaluation (ODE) receives approximately 6500 Premarket Notification (5100) submissions every year. Many of these submissions are incomplete or grossly inadequate, as they fail to contain the components necessary to allow substantive review of the submission and inappropriately consume Center resources. As a means to employ more effectively the Centers resources, the FDA has implemented procedures to ensure that 510Ks meet a minimum threshold of acceptability; otherwise the Center will refuse to accept the submissions for substantive review.

The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly.

Our expert Angela Bazigos help you to understand the various cause of refusion to accept 510(k) Submissions.

Why should you attend:

In this webinar, you will learn what the FDA expects for a 510K submission. By following the principles outlined in this webinar, you will minimize the risk of your submission being rejected and you will increase the potential for a speedy review and approval by the agency.

Session Highlights:

  • FDA’s Guidance on Refuse to Accept
  • Pre-Submission Interaction
  • 510(K) Refuse to Accept Policies and Procedures High Level
    • the 510(k) Checklist
    • FDA Review Clock
    • Notification of Acceptance Review Result
  • Refuse to Accept Principles – Details
  • Refuse to Accept Checklist – Details
  • Acceptance Review Checklist  Details
  • Traditional vs Non-Traditional 510(K)s



Use “FDA40” to get $40 Off.
Attend in a Group and save upto 50%. Email us at for bulk orders.

3PLs & 4PLs – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

On-Demand Webinar Duration: 61 Min


In addition to providing traditional transportation and logistics services, today’s 3PLs and 4PLs provide a wealth of value to their food and beverage customers. Join industry executives for a roundtable discussion about this evolving role and how it affects the expectations and relationships between 3PLs/4PLs and their customers.



Todd Ewing
Director – Product Management

Ewing has more than a decade of experience in B2B software. Prior to his current role at Verizon Telematics, he has held a number of leadership positions in marketing, including Senior Product Manager at SageQuest, where he was responsible for managing marketing programs and demand generations efforts. Prior to that, Ewing was the Channel Manager at D&B, where he successfully developed and supported a program to introduce products into inside sales channels. He holds a Bachelor of Arts and a Bachelor of Science in Creative Writing and Mass Communications from Miami University.


Michael A. Jones
Senior Vice President — Development and Innovation

Mike leads Armada’s growth strategy and the development of services in the marketplace for outsourced supply chain solutions. This includes the services necessary to achieve client objectives and satisfy marketplace demands, and encompasses the continued innovation of Armada’s service offerings for outsourced supply chain solutions, strategic partnerships, mergers and acquisitions.

Mike has been with Armada for 13 years with responsibilities for profitable business growth and new service development, strategic client partnerships, and business development. Mike has 25 years of business strategy and management experience, with 20 years in the foodservice industry innovating and transforming supply chains for companies ranging from Fortune 500 to privately held.

Mike holds a B.S. in Industrial Engineering from the Rochester Institute of Technology (RIT).


Marc D. Lebovitz
Romark Logistics

Marc Lebovitz is President of Romark Logistics and has been actively involved in all facets of the business as employee and owner since 1991. As President, he oversees all strategic and daily operations of the company. Romark is a leading third-party logistics provider that focuses on personalized service for small to multi-national companies, specializing in the food & beverage industry. It operates more than 6 million square feet of warehouse space with locations in NJ, PA, TX, GA and CA.

Marc also serves as a Principal of Woodmont Industrial Partners, which owns and manages a portfolio of more than 2.5 million square feet of industrial properties. Woodmont Industrial Partner investments focus on globally oriented seaport and inland port markets in the Eastern United States.

Professional Development Meeting – 2018 April 26th

Tutorial Meeting Topic:
Running Hurdles – Winning at Quality

Presentation Topic:
Online Marketing – Find & Connect with potential Prospects & Clients

Register Now !

Starting at 6:15pm with a two speaker Panel session: Running Hurdles: Winning at Quality

What hurdles does your company face day to day? Learn how to navigate possible project pitfalls and find solutions from those who have already experienced them through an interactive case study presentation. These same hurdles, including obstacles to communication, lack of empowerment of the right people within a team, suppliers who do not have the expertise needed, inadequate project planning and project management are encountered in many industries. Patti Rossman and Cody Mahaffey lead Globiox, a Life Sciences consulting firm whose team has many years of experience in every facet of quality compliance within their industry. They will cover some of the main hurdles and solutions seen throughout quality, but also the issues that are more behind the scenes which spurred Patti Rossman to create Life Science Women’s Conference.

Dinner will follow the panel session at 7:10pm to include monthly announcements and updates for the month.

Our After Dinner topic (7:30pm) will feature Integrated Marketing and Certified Social Media Strategist Terry Sullivan who will address the topic of how businesses and individuals can effectively use the latest online marketing tools to find and connect with potential prospects and clients.

Widely considered to be a “Guru of LinkedIn Terry has trained more than 6,200 business leaders, owners and individuals across the nation on how to create a unique online brand that gets results. His inspiring training programs focus on keyword optimization, branding and Social Selling strategies that help his clients tap into the unlimited world of Social Media to get better leads, more prospects and clients.

Meeting Date: April 26, 2018
Meeting Time: 6:00 to 8:30
Dinner Price: $25.00

Meeting Location:
Crowne Plaza Addison
14315 Midway Rd, Addison, TX 75001

Register Now !

Cowtown Quality Roundup 2018


Registration is Open



Add to Calendar


Friday, April 20, 2018

8:00 am – 5:00 pm


Radisson Hotel

Fort Worth North – Fossil Creek



Cost: $127 – a Great Value!

Includes: Continental Breakfast, Buffet Lunch, Afternoon Break


Memory Jogger, Door Prizes, CA$H Lotteries

Sorry… no early bird or multi-person discounts are available.

We give equivalent back in the 2-3 Lotteries valued $50 to $250


Immediate payment by credit card is the default…

for alternative payment methods contact


For more details in including program choices, see or download flyer below…



Professional Development Meeting – 2018 March 22nd

Tutorial Meeting Topic: Job Hunting in the Metroplex

After Dinner Meeting Topic: The Human Side of Quality: Employee Engagement and Quality Improvement

… and you definitely do not want to miss this meeting because the Easter Bunny will be leaving gifts (more details below)…

IMPORTANT NOTICE:Please make your reservations for this meeting only by email to Please include your name and note if you are planning to eat dinner. You will receive a email reply for conformation. We are currently updating our website and are not quite ready to receive reservations through the site as of yet. We should have everything working by April.


This month Our Tutorial will offer the opportunity for you to work directly with DFW metroplex recruiters on your strategy for new job opportunities. Although this will be especially important to those of you currently not working looking for employment it is also great for all of us to keep resumes current and understand what the job market outlook is for this coming year and beyond. We will have several recruiters on hand which will be present initially in a panel format for questions and then also individually for specific guidance.

Our after dinner presentation will feature Don Swift, Don has worked 46 years in Quality Management and Human Resources in the automotive, office products, large equipment manufacturing, criminal justice, graphite manufacturing, and household goods moving industries. He has served as project manager for the implementation of ISO 9001/AS9100 for 5 companies. Today Don owns and operates his own business, Don Swift and Associates, LLC, which focuses on “The Human Side of Quality”. The Company analyzes and proposes suggestions on the continual improvement of his clients’ quality and/or human resources systems – from implementation to revision. Since he specializes in the “human side” – engagement, training, competency, and cultural improvements are at the center of the plans for success. Don holds a Bachelor’s Degree in both Education and Psychology and a Masters in Organizational Leadership. He is a Certified Quality Improvement Associate, as well a certified Lead Auditor for ISO 9001, AS9100 and TS 16949 and a Lean Six Sigma Black Belt. Don is a Senior Member of the American Society for Quality, and a long-time member of the Society for Human Resources Management.

Don’s Presentation Highlights:

  • The Importance of Leadership
  • The Employee Engagement Factor
  • 59% more growth in revenue per employee is doable
  • Critical strategy: selecting and deploying the right managers/employees
  • Development of the Employee Engagement Culture

Researchers have made huge strides in understanding human behavior and motivation over the past decade. Few businesses actually apply these discoveries when strategizing for improvement or even retention of “star” employees. The result: companies are missing opportunities for growth and revenue because they do not understand the impact of human nature in the workplace.

The Goal

  • The goal is clear, implement and sustain a performance excellence system with the understanding that it will make money.
  • A senior management team intent on improving its organizational practices has a choice of models to emulate. They can follow the 18th century model and ask, “Who should we involve?” or they can go directly to the 21st century model and ask, “Who can we afford to exclude?” The answer is “Nobody!”
  • 100% involvement in any continual improvement, or performance excellence, effort is essential. How do we get there?



So please do look forward to prizes that will be left behind such as Books, Totes, a Hotel stay for two, complimentary dinner meeting tickets to future meetings as well as a few other surprise gifts including cash money!!!!!!!

Please make your reservations soon by email to Please include your name and note if you are planning to eat dinner. You will receive a email reply for conformation.

Meeting Date: March 22, 2018
Meeting Time: 6:00 to 8:30
Dinner Price: $25.00


Crowne Plaza Addison
14315 Midway Rd, Addison, TX 75001


Tutorial Slides: Resume / Interview 101 – Kent Smith

Presentation Slides: The Human Side of Quality – Don Swift