The January 2018 PD Meeting has been cancelled.
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:
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.
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 Date: November 29, 2018
Meeting Time: 6:00 pm to 8:30 pm
Dinner Price: $25.00
Crowne Plaza Addison
14315 Midway Rd, Addison, TX 75001
Presentation Slides: A&M Commerce College of Business – Overview
Don’t miss the 2018 Midwest FDC Conference
October 3, 2018 at Wojcik Conference Center – Harper College
Members: $100 Non-Members: $120
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
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.
Live Webinar on Oct 12, 2018 | 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes | By: Danielle DeLucy
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.
Areas Covered in the Webinar: