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


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


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


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


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

Professional Development Meeting – 2018 September 27th


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 !


Tutorial Slides: Resume / Interview 101 – Kent Smith

Presentation Slides: Changing Regulatory Climate for Medical Device Manufacturers

Software & Technology II – Webinar

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

Live Webinar on Oct 17, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT | Duration: 60 Min 



Software and technology touches virtually every aspect of the global food supply chain. The positive impact on time- and temperature-sensitive perishables is especially profound, helping to support longer and more complex supply chains, omnichannel grocery, regulatory compliance and recall events, to name a few.


Lean 6-Sigma SIG – Monthly Meeting – 2018 September

Topic:  An Introduction to TRIZ, The Theory of Inventive Problem Solving

Ever been stuck on a problem with no idea how to attack it? Or, come up with a solution that was just too complicated to implement? At this month’s meeting com learn about TRIZ (теория решения изобретательских задач), the Theory of Inventive Problem Solving. TRIZ is a systematic approach to understanding your problem, finding a solution, and simplifying complex designs. How you ask? Because through TRIZ you will learn that someone somewhere has already solved your problem.

Speaker Bio

John Ellis is currently Sr. Manager – Continuous Improvement and Strategic Project Portfolio, HR and Legal for NEC Corporation of America. He is a PMI certified PMP (Project Management Professional), an ASQ Certified Six Sigma Black Belt and a Textron Certified DFSS Black Belt and Master Black Belt. Prior to entering the world of Six Sigma he created and then managed the IT Project Management Office at Bell Helicopter. He has a long and varied IT background including managing data networks, IT product and vendor management, developing application architecture and standards, and operating systems programming. He is a graduate of the University of Southern California with a BA in Mathematics and German. John enjoys classical music and Broadway shows, plays piano, and is interested in foreign languages having studied French, Chinese Mandarin and American Sign Language in addition to his degree in German.

For more details: Calendar Event

Pest Management’s Role in Food Safety and FSMA Compliance – Webinar

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

Complimentary Webinar on Sep 26, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT


Complimentary Webinar

Pest Management’s Role in Food Safety and FSMA Compliance


Pests are a major threat to the integrity of food products and a threat to any facility’s bottom line. With the Food Safety Modernization Act (FSMA) in full effect, preparation is more important than ever. FSMA mandates a proactive approach to food safety, and by extension pest management. It’s important to have an Integrated Pest Management program in place that is exhaustive and integrates seamlessly into the overarching food safety plan.

Join Orkin’s Chelle Hartzer and Savour Food Services International’s Gina Kramer, as they bring their knowledge and expertise to your facility with a free webinar to discuss preventive pest management controls that should be implemented to help ensure you and your staff are operating the safest food facility possible.

Learning Objectives:

During this free, hour-long webinar you’ll learn about:

  • Key componentsof FSMA as they relate to pest control
  • Common factors that affect preventive controls
  • Establishing preventive controls
  • How to measure success with an IPM Plan

Who Should Attend:

During this free, hour-long webinar you’ll learn about:

  • Food Processing Professionals
  • Quality Assurance Directors


Chelle Hartzer, BCE
Chelle Hartzer, BCE Technical Services Manager Orkin
Gina R. Nicholson-Kramer, RS REHS
Gina R. Nicholson-Kramer, RS REHS Executive Director, Savour Food Safety International