2019 World Conference – Volunteers Wanted

The ASQ World Conference on Quality and Improvement (WCQI) is coming to Ft Worth next year. After years of seeking it, we got a surprise in Dec 2017 with the announcement Fort Worth would be the Host City. WE ARE EXCITED!

We have formed a Core Site Committee of members from both Ft Worth and Dallas Sections. This team attended the Seattle WCQI in May, met in June to discuss our approach, and are now ready to take the names of members who want to volunteer to staff it.

Volunteer Role/s include:

  • 8 total hours of volunteer time (single / multiple days)
  • Monitor Session Presentation Rooms – room administration
  • Information Tables – conference and Ft Worth City opportunities
  • General Help – background support of the attendees / conference

It will be held at the Ft Worth Convention Center and the Omni Hotel, Sat to Wed, May 18-22, 2019. Staffing include weekend jobs. Volunteers get complimentary entry to the 3-Day Conference (a $1000+ value).

To register your interest in being a volunteer, we are accepting member names. This is not yet a firm commitment, as we will not know our actual staffing requirements until Feb 2019. A confirmation of availability will be sent to those signing up now at www.tinyurl.com/WCQI-2019-VOL.

Professional Development Meeting – 2018 November 29th

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Presentation:

TAMU-C Business Management/Quality Partnering Opportunities

Topics:

  • Overview of the TAMU-C College of Business management programs coming in Spring 2019
  • Soft Sills: Leadership, Organizational Behavior, Communication, and Strategic Management components of programs
  • Managerial Tools and Techniques components of programs (Project Management, Supply Chain, Operations and Six Sigma)
  • Pilot Program: Results from strategic partnership with L-3

 

About the Speakers:

Dr. Mario Hayek is an Associate Professor and the head of the management department in the College of Business at Texas A&M Commerce. He obtained an MBA with emphases in Finance and Entrepreneurship from the American University in Washington D.C. and a Ph.D. in management from the University of Mississippi; he has been teaching for over 20 years. As an entrepreneur, Dr. Hayek has launched a number of new ventures in Latin America and the Unites States including a recycling plant, hotel, restaurants, bar, travel agency and commercial real estate. As an academic, his research interests include entrepreneurship, leadership, organizational behavior, social responsibility and ethics.

Dr. Alex Williams is an Associate Professor in the College of Business at Texas A&M Commerce, where he teaches organizational behavior and human resources. His primary research interests include Leadership & Organizational Behavior. He earned his Ph.D. in Management at The University of Mississippi and his BA in Accounting from Morehouse College (Atlanta, GA).  He is a 2017 Hunt/Hopkins County Professor of the year, the 2016 recipient of the Neill Humfeld Distinguished Faculty Award for Service, and the 2015 Faculty Senate Award for Teaching with Technology. Additionally, he has extensive experience as both a business professional and a social entrepreneur.

Dr. Jerry Burch is an Assistant Professor in the College of Business at Texas A&M Commerce and has over 25 years of Supply Chain experience focusing on process improvement and time series forecasting. He received his Masters of Science in Operations Research/Operations Logistics and earned his Master Blackbelt while working with the Defense Logistics Agency. He has also earned his Ph.D. in Management (Organizational Behavior) with minor area of study in Decision Sciences. His research has been published in many top rated journals including the International Journal of Forecasting and Decision Sciences Journal of Innovative Education.

 Tom Brown completes a 35 year career, retiring as Senior Vice President of Human Resources for the Aerospace Systems Segment at L3 Technologies at he end of this year. Tom has extensive HR experience as a specialist in compensation, information systems, management development training, staffing, and benefits as well as in HR generalist roles throughout his career. His previous employers include Raytheon, Alcatel and Bank One. He holds a Master of Business Administration in human resource management from the University of Dallas and a Master of Liberal Arts from Southern Methodist University.  He also serves as Vice Chairman of the Board of Trustees for Lakes Regional Community Centers (MHMR), and is a member of the Autism Society of America.

 


Meeting Information

Meeting Date: November 29, 2018
Meeting Time: 6:00 pm to 8:30 pm
Dinner Price: $25.00

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

Register Now !

Update!

Presentation Slides: A&M Commerce College of Business – Overview

Professional Development Meeting – 2018 October 25th

Risk and Regulatory Compliance – 2018 Midwest FDC Conference

Risk and Regulatory Compliance

Don’t miss the 2018 Midwest FDC Conference

October 3, 2018 at Wojcik Conference Center – Harper College

Palatine, Illinois

Regulatory authorities have embraced science-based risk management.  As the supply chain becomes more complex, risk awareness and quality aspects in general become more important.
All countries involved in regulated industries should have quality processes for sourcing of materials, manufacturing, packaging, testing, storage, and distribution.  These quality processes provide rationale to understand risk, as well as to mitigate it through appropriate and robust controls.

Members:  $100  Non-Members:  $120

Developing a Strategic Approach to FDA Compliance for Computer System Validation – Webinar

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

Live Webinar on Oct 10, 2018 | 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes | By: Carolyn Troiano

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You will learn how to take a strategic approach to validating computer systems that are regulated by FDA in a way that will be cost effective and efficient. The webinar will go through the System Development Life Cycle (SDLC) methodology in detail, and we will demonstrate how the SDLC supports Computer System Validation (CSV).

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these forms the basis for any CSV project. The importance of the sequence of steps will also be covered.

Why Should You Attend

An FDA inspection or audit is something to take very seriously, and it’s important to have all computer systems that are regulated by FDA fully validated. In this FDA Compliance training, you will learn how to validate computer systems in compliance with FDA’s guidelines and also how to maintain them in a validated state. This will provide you with a level of certainty that you will be able to respond to FDA questions and provide the documentation necessary to defend your approach and body of work.

Learning Objectives:

  • Learn about industry best practices related to compliance and computer system validation
  • Learn about strategies for reducing the cost and complexity of compliance with FDA regulations
  • Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process
  • ….. and more

Session Highlights:

  • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Validation Strategy that will take into account the system risk assessment process
  • ….. and more

CLICK HERE TO REGISTER

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

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More – Webinar

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

Live Webinar on Oct 12, 2018 | 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes | By: Danielle DeLucy

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The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

Why Should You Attend

Failure to adequately assess and control your supplier/subcontractor pool can result in dire consequences for an organization. Assessing and approving your suppliers before placing the first order with them will eliminate many headaches for a medical device manufacturer.

Many organizations conduct supplier audits because they are required to do so by their customers or a regulatory agency. Others conduct the audits because they have been led to believe that it’s a good tool for comparing various suppliers against an arbitrary list of criteria.

While all of these reasons have varying degrees of validity, none of them articulate the best reason for having a robust supplier audit program. A good supplier audit program should allow an organization to assess and periodically re-affirm the ability of key suppliers to provide conforming product consistently, reliably and on-time. It should be one of the most important initiatives toward fulfilling the goal of having a sustainable supply chain.

Learning Objectives:

  • Understanding the FDA’s requirements for medical device supplier assessment and approvals
  • Learning “who” are considered to be suppliers
  • Knowing how to structure a supplier quality agreement
  • Selecting the potential methods for evaluating and assessing suppliers

Areas Covered in the Webinar:

  • Regulatory requirements for supplier qualification
  • Responsibilities of manufactures and suppliers
  • Best practices for supplier selection, qualification and management
  • What are the FDA’s expectations in regards to quality agreements?
  • What is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance?
  • Best practices for a good quality agreement
  • Supplier audits
  • Documentation requirements and audit trails

CLICK HERE TO REGISTER

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

Professional Development Meeting – 2018 September 27th

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Tutorial: Resume/Interview 101 by Kent Smith

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.

About the Speaker:

Since the past 9 years, Kent Smith a Senior Business Development Manager for Talent 101, Inc. Talent 101 has been a global workforce solution provider dedicated to the semiconductor industry offering contract, direct-hire, statement of work and strategic outsourcing. Prior to working for Talent 101, Kent was a Client Services Representative for Business Control Systems where he was nominated for outstanding service, personnel and pricing to Texas Instruments providing I.T. staffing solutions.

Besides the semiconductor industry, Kent has also worked in sourcing professionals from a variety of disciplines and industries in the past.

Presentation: Terrina Wilder – TW Consulting and Associates

About the Speaker:

Terrina Wilder entered the US Army from her home state of Wisconsin in 1988. Her military career as a Medical Specialist and Chemical Officer would ultimately open opportunities in industries such as primary healthcare, veterinary medicine, chemical manufacturing, drug development, and medical device manufacturing. Terrina has been in the Regulatory Affairs profession since 2000 and has been a certified RA professional since 2005. Her specialty has been global regulatory compliance for the medical device industry for the last 18 years. TW Consulting and Associates was established in 2011 by Ms. Wilder and has serviced start-up, mid-size, and large medical device companies. TW Consulting and Associates has helped companies market their products in over 60 countries and strategically addresses worldwide regulatory compliance concerns. In her spare time, Terrina enjoys living in the North Dallas, Texas area where she hikes, occasionally attends theatre productions, and is an active member of her local church.

 

Meeting Information

Meeting Date: September 27, 2018
Meeting Time: 6:00 pm to 8:30 pm
Dinner Price: $25.00

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

Register Now !

Update!

Tutorial Slides: Resume / Interview 101 – Kent Smith

Presentation Slides: Changing Regulatory Climate for Medical Device Manufacturers