“The SWOT Approach to College Enrollment” by Kelly Rodkey

As my family navigates the college search, application, and selection process for our second child, I yearn for a tool to distill the 4000+ degree granting universities into a handful for consideration.

I sought out the SWOT (Strength Weakness Opportunity Threat) Analysis as my salvation.  I quickly realized all the facts and data were available for these schools, so what I really needed was selection criteria for differentiation.

Strengths related to available field of study, admission criteria test scores, size of student body, public or private institution, scholarship availability, geographic location, and even academic reputation.

Weaknesses related to available field of study, admission criteria test scores, size of student body, public or private institution, scholarship availability, geographic location, and academic reputation as well.

As I focused strengths and weaknesses of the internal environment, such evaluation became only one part of the whole.  I focused on the opportunities and threats of the external environment and, in this case, those affected by the perceptions of a teenager trying to plan for the rest of her life.

Will it matter how good the food is in the cafeteria, how far one has to walk to get to class, how many flights of stairs are beautifully incorporated into the treks across campus, how many people from high school are going to the same university, how good/poor the lighting is in the dormitory, how nice the professor was during the interview, the strength of campus safety measures, how close the university is to civilization (as defined by a teenager), etc.,?

SWOT looks at how a firm fits to the current reality, so it is a preliminary indication of current competitive position.  Reality for a teenager may change rapidly.

SWOT analysis should be based on objective data that allow past-to-current-to-probable future comparisons of the marketplace, competitors, products and services, and company performance.  SWOT can help narrow the field in the college search using institutional facts and data.  However, as selecting a university to commit to for about four years of her life requires identifying where she is most comfortable, it seems that no quality tool can help characterize the highly subjective and emotional traits that will make a particular university the right fit for my child.

Kelly Rodkey spent over 22 years in the healthcare industry at Abbott and Baxter in many quality roles, which encompassed testing and manufacturing, new product development, and clinical study report submissions.  In her most recent role as a CAPA Quality Approver, Kelly worked with investigation teams to ensure nonconformances were fully investigated, corrective and /or preventive actions were effective, and documentation narratives were understandable and fully supported.  She holds three ASQ certifications and has been a member of ASQ Section 1212 since 2009.

2017 Mini-Course from our Wisconsin sister-section

An Interrelated Look at ISO 9001:2015 

AND

Leadership Through The Eyes of ISO 9001:2015

 

ASQ Section 1216  La Crosse – Winona 

Tuesday, April 4th, 2017 4:00-7:30pm 

WTC Lunda Center, La Crosse, WI 

$25 Members and Guests $10 Students 

 

 

 

 

Register online at http://asq1216.pingg.com/AsqSection1216Mini by March 27. 

  

Presented By: Robert Freeman 

Where is your organization in implementing ISO 9001:2015? Whether you implemented immediately or are still in the process of evaluating your systems, our mini conference will give you a new take on the changes and how to improve your systems.

Bio: Robert Freeman is president of Practical Perspectives in McKinney, TX. He is a U.S. technical expert on the next revision of ISO 9004 and is a member of the U.S. Technical Advisory Group (TAG) to ISO Technical Committee (TC) 176. Freeman is a senior member of ASQ, a registered lead auditor for ISO 9001 and an ASQ-certified quality improvement associate.

An Interrelated Look at ISO 9001:2015 

Join us to explore the relationship of strategic direction and purpose of the management system, gain an understanding how to address requirements that lack an expectation for documented information and what maintained and retained documented information means and how to apply it effectively, learn the application of risk-based thought, understand competence versus organizational knowledge and transitioning to a business-centric management system.

Leadership Through the Eyes of ISO 9001:2015 

While some of us were losing sleep over the risk-based thinking requirements ISO 9001:2015, others realized that the role of leadership was equally critical in the implementation of the new standard. Learn how the new standard more clearly addresses the role of leadership in the organization’s management system, the importance of understanding an organization’s purpose and strategic direction within the context of the management system. Invite your leadership to join the discussion and learn about their new role.

Agenda: 

4:00-4:15 networking and registration

4:15-5:30 An Interrelated Look at ISO 9001:2015

5:30-6:00 dinner

6:00-7:30 Leadership Through the Eyes of ISO 9001:2015

Dinner: 

Dinner will be a choice of Chicken Marsala or Asparagus Gnocchi served with couscous and an assortment of roasted seasonal vegetables.

The Lunda Center is highlighted in blue. Parking for the Lunda Center is available in lot L.

ASQ Section 1212 Newsletter, March 2017

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Membership Meeting: March 16, 2017

 

4:00 – 5:00 Factory Tour – Plexus, 2400 Milbrook Dr., Buffalo Grove, IL

5:00 – 5:30 Dinner and Networking; Training Room, Plexus

5:30 – 6:30 Post- Dinner Presentation: Electronic Finished device manufacturing, Robin Dunham

Follow this link to register:  https://www.eventbrite.com/e/asq-section-1212-march-plant-tour-meeting-and-dinner-tickets-27442622623

Note: Please come 15 minutes before the event begins to sign in. Everyone needs to get a security badge prior to the factory tour.

For this ASQ NEI Section 1212 Event only, the ticket price is $14 through Eventbrite and $17 at the door.

If you wish to attend the meeting  and forego dinner, please sign up for the ticket titled “ASQ Section 1212 September Meeting WithoutDinner.” Dinner is free to unemployed members. If you wish to attend the meeting and are unemployed please sign up for the Event titled “ASQ Section 1212 September Meeting Courtesy Dinner.” Please be prepared to provide your personal membership number at the door.

 

Plant Tour:

Plexus Corp. (Plexus) and its subsidiaries are engaged in the electronic manufacturing services (EMS) industry. The Company delivers end-to-end solutions for customers in the Americas (AMER), Europe, Middle East, and Africa (EMEA) and Asia-Pacific (APAC) regions. The Company’s segments are AMER, APAC and EMEA. The Company’s customer-focused solutions model integrates product conceptualization, design, commercialization, manufacturing, fulfillment and sustaining solutions. The Company delivers solutions to its customers through its product realization value stream. The Company provides customer services to about 140 branded product companies in the healthcare/life sciences, industrial/commercial, networking/communications and defense/security/aerospace market sectors.

The Company’s product design includes various solutions, such as program management; feasibility studies; specification development for product features and functionality; Circuit design (digital, microprocessor, power, analog, radio frequency (RF), optical and micro-electronics); field programmable gate array design (FPGA); printed circuit board layout; embedded software design; mechanical design (thermal analysis, fluidics, robotics, plastic components, sheet metal enclosures and castings); test specifications development and product verification testing, and automated (robotic) production solutions and complex automation design. Its Design for Excellence (DFX) solutions encompass a range of specific design solutions, including design for test, design for manufacturability/assembly and design for fabrication. Its manufactured products fall into one of the categories in its assembly spectrum, including printed circuit board assembly, basic assembly, system integration and mechatronic integration.

The Company provides a range of aftermarket services, including complex repair, refurbishment and product support for products it manufactures. In addition, it also provides customized solutions for products it does not manufacture. Its aftermarket services offerings include screening, loaner program, part harvesting, in/out warranty repair, advanced exchange, part repair, upgrade, demo unit management, warranty redemption, recycling, part fulfillment, decontamination, destruction, part fulfillment with warranty redemption, complaint handling and part sales. Plexus offers fulfillment and logistics solutions to its customers in the forms of Direct Order Fulfillment (DOF), Build to Order (BTO) and Configure to Order (CTO).

Post-Dinner Presentation: Electronic Finished device manufacturing, Robin Dunham

Summary:

Presentation is an overview of Plexus and the process for manufacturing FDA regulated Finished Medical Devices.  It covers receipt of Raw Materials through Product release.  Circuit Board manufacture, assembly and Functional testing.  This is a short version of what Plexus presented at FDA headquarters 5 times since 2008.

 Bio:

Robin is a 13 years veteran in the Quality function at Plexus.  He is considered the expert in the application of the Circuit Board manufacturing standard related to Soldering quality.  He is also in-house CAPA coordinator reporting on each CAPA status on a weekly basis.  He has been an ASQ member for 9 years.

 

Read more.

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“Root Cause Analysis to Address Health Concerns” by Kelly Rodkey

My daughter recently developed a skin condition that the pediatrician could not identify.  In her frustration, she declared, “Well I want to get a definitive diagnosis, not spend a year chasing around and guessing what it is!”

It reminded me that root cause analysis can be used to diagnose a medical condition.  Routine monitoring of human clinical chemistry can find an “out-of-specification” value in need of investigation.

As an example, Lee routinely got annual physicals.  Health insurance companies encouraged it and she thought it was a valuable investment as she realized she was no longer an invincible twenty-something.  At the office exam everything looked great, healthy weight and no major complaints.  She thought the insomnia, fatigue, joint pain, and trouble with concentration, were just a result of age and the hectic schedule of a working mother of three.  However, the routine lab work showed that Lee’s iron levels were quite low even though she took iron supplements since the birth of her then 10-year-old son.

It took multiple blood tests, fluid samples, and an upper and lower endoscopy to finally diagnose the root cause of the low iron level.  However, once clinicians identified the autoimmune disease, a  solution could be implemented… effectiveness is to be determined.

It would be nice if medical diagnoses could be swift and accurate, but as is often the case in industry, if the needed data are not available to identify the cause, then a well-planned investigation to collect more data must begin.

How will you manage your own health?  An annual physical allows the physician to monitor routine clinical chemistry values and to identify when something is trending out of specification.  Once the out of specification condition is identified, the investigation can begin.  With luck, the root cause can be quickly diagnosed, solutions can be identified and implemented, and the effectiveness of the solution can be evaluated… all with facts and data and not prolonged physician guessing.

Kelly Rodkey spent over 22 years in the healthcare industry at Abbott and Baxter in many quality roles, which encompassed testing and manufacturing, new product development, and clinical study report submissions.  In her most recent role as a CAPA Quality Approver, Kelly worked with investigation teams to ensure nonconformances were fully investigated, corrective and /or preventive actions were effective, and documentation narratives were understandable and fully supported.  She holds three ASQ certifications and has been a member of ASQ Section 1212 since 2009.

Read more.

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Click “Read more” to see a complete listing of the SLC.

Your Section Leadership

The Section Leadership Committee (SLC) is comprised of volunteers from your section.  Feel free to contact them using the email addresses listed below. If you need help navigating our website, have questions or have an idea for improvement contact our webmaster Adela Crandell Durkee at  website@asq1212.com If you want to submit something to the Newsletter, don’t know how to sign-up, are missing …

Read more.

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On-line CMQ/OE Exam Prepreparation



ASQ Certified CMQ/OE Exam
Online Class

Manager of Quality & Operational Excellence

– Presented by ASQ Section 1302 –

Instructor: Mr. Rick Pennington, CMQ/OE, CQE

 

Class dates: March 20 – May 7, 2017

(Class Enrollment Deadline: March 12, 2017)

CMQ-OE exam dates: May 5 – 21, 2017

(Exam Registration Deadline: April 7, 2017)

From the cozy comfort of your home!

Just Imagine: You can do all this…… without leaving town!

  • Attend an Online CMQ/OE Prep course and prepare for the exam
  • No need to travel to another city for multiple weeks
  • No need to lose time from work
  • No need to lose family time

 

Here are the ways you can $Save$ BIG:

  1. Travel expense (flight, drive, gas, depreciation & maintenance)!
  2. Lodging and hotel bills
  3. Food and incidentals due to travel
  4. Tuition and registration: This 7-week online class will cost you only $400! Compare to $600+ price tag if you take the National ASQ prep-course which is self-study and does not include instructor and group interaction. (Note: price does not include Primer and recommended course material).

 

What to Expect

  1. Pre-exam to evaluate current knowledge of CMQ/OE BoK.
  2. Weekly readings from the primer and articles pertinent to CMQ/OE exam
  3. Weekly homework Modeled after CMQ/OE exam
  4. Weekly open-ended Questions as homework to prepare for the closed-book portion of CMQ/OE exam.
  5. Weekly Discussion Board: Communicate & interact with your instructor and your classmates
  6. Videos that reinforce learning course concepts and the CMQ/OE body of knowledge
  7. Opportunity to simulate the exam: A mini version (approximately 2.5 hours) of a mock exam will be available so you can practice taking the test under timed setting.
  8. You must order and pay for the required Primer (and other optional course resources). Links and approximate cost are available at the website. Allow 5-7 days for delivery.
  9. Recertification Units (RU) = 2.0 after successful completion of course. Signed certificate will be emailed.

 

Don’t lose out on this great opportunity!

Enroll in this class TODAY


The last day to enroll for class is:  Monday, March 12

 

Enroll here!                                         http://www.asq-1302.org/education-and-training/

 

Once enrolled, you will be directed to another page where you can make a credit-card payment.

Membership Meeting: March 16, 2017

4:00 – 5:00 Factory Tour – Plexus, 2400 Milbrook Dr., Buffalo Grove, IL

5:00 – 5:30 Dinner and Networking; Training Room, Plexus

5:30 – 6:30 Post- Dinner Presentation: Electronic Finished device manufacturing, Robin Dunham

Note: Please come 15 minutes before the event begins to sign in. Everyone needs to get a security badge prior to the factory tour.

For this ASQ NEI Section 1212 Event only, the ticket price is $14 through Eventbrite and $17 at the door.

If you wish to attend the meeting  and forego dinner, please sign up for the ticket titled “ASQ Section 1212 September Meeting WithoutDinner.” Dinner is free to unemployed members. If you wish to attend the meeting and are unemployed please sign up for the Event titled “ASQ Section 1212 September Meeting Courtesy Dinner.” Please be prepared to provide your personal membership number at the door.

Plant Tour:

Plexus Corp. (Plexus) and its subsidiaries are engaged in the electronic manufacturing services (EMS) industry. The Company delivers end-to-end solutions for customers in the Americas (AMER), Europe, Middle East, and Africa (EMEA) and Asia-Pacific (APAC) regions. The Company’s segments are AMER, APAC and EMEA. The Company’s customer-focused solutions model integrates product conceptualization, design, commercialization, manufacturing, fulfillment and sustaining solutions. The Company delivers solutions to its customers through its product realization value stream. The Company provides customer services to about 140 branded product companies in the healthcare/life sciences, industrial/commercial, networking/communications and defense/security/aerospace market sectors.

The Company’s product design includes various solutions, such as program management; feasibility studies; specification development for product features and functionality; Circuit design (digital, microprocessor, power, analog, radio frequency (RF), optical and micro-electronics); field programmable gate array design (FPGA); printed circuit board layout; embedded software design; mechanical design (thermal analysis, fluidics, robotics, plastic components, sheet metal enclosures and castings); test specifications development and product verification testing, and automated (robotic) production solutions and complex automation design. Its Design for Excellence (DFX) solutions encompass a range of specific design solutions, including design for test, design for manufacturability/assembly and design for fabrication. Its manufactured products fall into one of the categories in its assembly spectrum, including printed circuit board assembly, basic assembly, system integration and mechatronic integration.

The Company provides a range of aftermarket services, including complex repair, refurbishment and product support for products it manufactures. In addition, it also provides customized solutions for products it does not manufacture. Its aftermarket services offerings include screening, loaner program, part harvesting, in/out warranty repair, advanced exchange, part repair, upgrade, demo unit management, warranty redemption, recycling, part fulfillment, decontamination, destruction, part fulfillment with warranty redemption, complaint handling and part sales. Plexus offers fulfillment and logistics solutions to its customers in the forms of Direct Order Fulfillment (DOF), Build to Order (BTO) and Configure to Order (CTO).

Post-Dinner Presentation: Electronic Finished device manufacturing, Robin Dunham

Summary:

Presentation is an overview of Plexus and the process for manufacturing FDA regulated Finished Medical Devices.  It covers receipt of Raw Materials through Product release.  Circuit Board manufacture, assembly and Functional testing.  This is a short version of what Plexus presented at FDA headquarters 5 times since 2008.

 Bio:

Robin is a 13 years veteran in the Quality function at Plexus.  He is considered the expert in the application of the Circuit Board manufacturing standard [IPC] related to Soldering quality.  He is also in-house CAPA coordinator reporting on each CAPA status on a weekly basis.  He has been an ASQ member for 9 years.

 

Certified Quality Engineer (CQE) Refresher Class

Purpose

To help prepare our members for the June 2017 CQE Exam, the Northeastern Illinois Section (1212) will be providing a CQE Refresher class

What is a Certified Quality Engineer?

“The Certified Quality Engineer is a professional who understands the principles of product and service quality evaluation and control. This body of knowledge and applied technologies include, but are not limited to, development and operation of quality control systems, application and analysis of testing and inspection procedures, the ability to use metrology and statistical methods to diagnose and correct improper quality control practices, an understanding of human factors and motivation, familiarity with quality cost concepts and techniques, and the knowledge and ability to develop and administer management information systems and to audit quality systems for deficiency identification and correction.” borrowed from ASQ.org

Why would I want to become a CQE? Continue reading

“Root Cause Analysis to Address Health Concerns” by Kelly Rodkey

My daughter recently developed a skin condition that the pediatrician could not identify.  In her frustration, she declared, “Well I want to get a definitive diagnosis, not spend a year chasing around and guessing what it is!”

It reminded me that root cause analysis can be used to diagnose a medical condition.  Routine monitoring of human clinical chemistry can find an “out-of-specification” value in need of investigation.

As an example, Lee routinely got annual physicals.  Health insurance companies encouraged it and she thought it was a valuable investment as she realized she was no longer an invincible twenty-something.  At the office exam everything looked great, healthy weight and no major complaints.  She thought the insomnia, fatigue, joint pain, and trouble with concentration, were just a result of age and the hectic schedule of a working mother of three.  However, the routine lab work showed that Lee’s iron levels were quite low even though she took iron supplements since the birth of her then 10-year-old son.

It took multiple blood tests, fluid samples, and an upper and lower endoscopy to finally diagnose the root cause of the low iron level.  However, once clinicians identified the autoimmune disease, a  solution could be implemented… effectiveness is to be determined.

It would be nice if medical diagnoses could be swift and accurate, but as is often the case in industry, if the needed data are not available to identify the cause, then a well-planned investigation to collect more data must begin.

How will you manage your own health?  An annual physical allows the physician to monitor routine clinical chemistry values and to identify when something is trending out of specification.  Once the out of specification condition is identified, the investigation can begin.  With luck, the root cause can be quickly diagnosed, solutions can be identified and implemented, and the effectiveness of the solution can be evaluated… all with facts and data and not prolonged physician guessing.

Kelly Rodkey spent over 22 years in the healthcare industry at Abbott and Baxter in many quality roles, which encompassed testing and manufacturing, new product development, and clinical study report submissions.  In her most recent role as a CAPA Quality Approver, Kelly worked with investigation teams to ensure nonconformances were fully investigated, corrective and /or preventive actions were effective, and documentation narratives were understandable and fully supported.  She holds three ASQ certifications and has been a member of ASQ Section 1212 since 2009.

Newsletter, February 2017

Dear reader,

 Our next meeting is February 16, 2017

 

The February membership meeting is at

Arboretum Club

401 Half Day Road, Buffalo Grove.

Members and non-members are always welcomed.

There is no charge for people who wish to listen to the speakers and forego dinner.

Although walk-ins are welcome, we strongly urge you to pre-register.

 

Door prizes of wine, books and other great gifts are given out every month.

 

Register for the February Meeting by using the link below:

 

https://www.eventbrite.com/e/asq-section-1212-february-meeting-and-dinner-tickets-27442471170?aff=eac2

 

 

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Pre-Dinner Meeting:

Presentation Topic:   Taking the Mystery out of Computer System Compliance by Deb Bartel

The aim of this presentation is to increase the comfort level on the subjects of computer system validation and electronic data integrity by answering these questions:

  • What is Computer System Validation (CSV)
  • Why should you perform CSV
  • Which systems need to be validated
  • What are the steps of the CSV process
  • What do you need to do to ensure the integrity of electronic data

During Networking Dinner:

CGMP and Postmarketing Safety Reporting Requirements for Combination Products by Jesse Vazquez

Jesse Vazquez from FDA Chicago district office will be present at our meeting to answer questions that our members may have. Jesse is a Medical Device Specialist (Biomedical Engineer / Investigator) at the Chicago district office.

Post-Dinner Meeting: cGMP and post marketing safety reporting requirements for combination products by Mark D. Kramer, MS, RAC

Mark D. Kramer, MS, RAC, is President, Regulatory Strategies, Inc., (www.regulatorystrategies.net), a regulatory consultancy specializing in medical devices and combination products.  He has more than 25 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration

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Your Section Leadership

The Section Leadership Committee (SLC) is comprised of volunteers from your section.  Feel free to contact them using the email addresses listed below. If you need help navigating our website, have questions or have an idea for improvement contact our webmaster Adela Crandell Durkee at  website@asq1212.com If you want to submit something to the Newsletter, don’t know how to sign-up, are missing …

Read more.

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Membership Meeting February 16, 2017

Click the links (in blue) below to view the Slideshow presentations:

Kramer ASQ CGMP and Postmarket Safety Reporting 2-16-17

Praxis Computer System Validation 2017 02

Attention:

The February membership meeting is at

Arboretum Club

401 Half Day Road, Buffalo Grove.

Pre-Meeting Presentation 5:30 – 6:00 pm

Dinner, Networking           6:00-7:00 pm 

Main Presentation             7:00 – 8:00 pm 

Reserve your spot by filling out the Eventbrite form at the end of this announcement.

Members seeking employment are eligible for the courtesy dinner.  Be prepared to show your membership number.


 

Pre-Dinner Meeting:

Presentation Topic:   Taking the Mystery out of Computer System Compliance

Many Quality Assurance professions are confident in their QA expertise for a wide array of topics, including manufacturing, laboratories, clinical trials, and QMS, but start to feel uncomfortable when computer systems are the focus.

The aim of this presentation is to increase the comfort level on the subjects of computer system validation and electronic data integrity by answering these questions:

  • What is Computer System Validation (CSV)
  • Why should you perform CSV
  • Which systems need to be validated
  • What are the steps of the CSV process
  • What do you need to do to ensure the integrity of electronic data

Biography: Deb Bartel is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.  She is a long-time leader of software quality and information system initiatives with over 25 years of experience in multiple industries, including pharmaceuticals, medical device, chemicals, and textile manufacturing.

Deb has great enthusiasm for applying practical, effective approaches to meet the quality and compliance challenges of the Life Sciences industry. She has been able to use LEAN, continuous improvement, and risk-based processes to reduce costs while maintaining compliance with both US and international regulatory agency expectations. Deb also has many years of experience managing international ERP, laboratory, pharmacovigilance, clinical, quality management, and financial systems projects in both regulated and non-regulated industries.

Since joining Praxis in 2007, Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.  She also leads a popular weekly webinar series on CSV and SQA topics such as Part 11, Annex 11, Cloud/SaaS in GxP, and Auditing Software Vendors.

Deb has BS-Information Systems and MBA degrees from the University of Wisconsin.  She holds ASQ certifications in quality auditing (CQA) and six-sigma processes (CSSGB) as well as a PMP from the Project Management Institute.

 

During Networking Dinner:

CGMP and Postmarketing Safety Reporting Requirements for Combination Products

Jesse Vazquez from FDA Chicago district office will be present at our meeting to answer questions that our members may have. Jesse is a Medical Device Specialist (Biomedical Engineer / Investigator) at the Chicago district office. He Conducts inspections of regulated industry including inspections related to product marketing applications. Investigates complaints of injury, illness, or death caused by a product regulated by the FDA. Trains and works with industry, State and local officials, consumers, and fellow colleagues on enforcement policies, methods, and interpretation of FDA regulations and their impact on public health. Combination products such as drug-coated devices, prefilled delivery devices, convenience kits and cross-labeled products, raise a variety of unique regulatory issues.  This presentation will focus on the current good manufacturing practice (CGMP) and very recently issued postmarketing safety reporting requirements for combination products.  We will review the underlying CGMP and postmarketing safety reporting requirements for drugs, devices and biological products, and the final regulations now in place that specify the additional requirements that manufacturers must implement for their combination products.  Key takeaways from each regulation including compliance timeframes, enforcement considerations and recommendations will also be addressed.

 

Post-Dinner Meeting:

Combination products such as drug-coated devices, prefilled delivery devices, convenience kits and cross-labeled products, raise a variety of unique regulatory issues.  This presentation will focus on the current good manufacturing practice (CGMP) and very recently issued postmarketing safety reporting requirements for combination products.  We will review the underlying CGMP and postmarketing safety reporting requirements for drugs, devices and biological products, and the final regulations now in place that specify the additional requirements that manufacturers must implement for their combination products.  Key takeaways from each regulation including compliance timeframes, enforcement considerations and recommendations will also be addressed.

Mark D. Kramer, MS, RAC, is President, Regulatory Strategies, Inc., (www.regulatorystrategies.net), a regulatory consultancy specializing in medical devices and combination products.  He has more than 25 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration, culminating in his position as Director of FDA’s Office of Combination Products from 2002 to 2007. Mark began his career in engineering and clinical/regulatory affairs positions in the medical device industry. He joined FDA’s Center for Devices and Radiological Health (CDRH) as a lead reviewer in the Pacing and Electrophysiology Devices Branch, and from 1990-1995 served as Chief of the Urology and Lithotripsy Devices Branch. He then went to the private sector, serving in both consulting and in-house corporate regulatory affairs capacities. Mr. Kramer returned to FDA in 1998 as Chief of CDRH’s Anesthesiology and Defibrillator Devices Branch until his appointment as Director, CDRH Staff College in 1999. He then served as Director of the Agency’s Combination Products Program from February 2002 until the establishment of the Office of Combination Products in December 2002, where he served as Director until April 2007.  As OCP Director, Mark led the development of policies, procedures and processes to ease the assignment, premarket review and postmarket regulation of combination products.  From 2007-2010, Mark was Vice President, Regulatory Affairs and Chief Regulatory Strategist at GE Healthcare.  Mark served on the Board of Directors of the Regulatory Affairs Professional Society (RAPS) from 2009-2014, served as Chair of the Wisconsin RAPS Chapter from 2007-2010, and is an adjunct faculty member for St. Cloud State University’s Master’s program in regulatory affairs.  Mark can be reached at kramer@regulatorystrategies.net.

Membership Meeting January 19, 2017

The January membership meeting is at Dover Straits, 890 East US Route 45, Mundelein.

Pre-Meeting Presentation 5:30 – 6:00 pm

Dinner, Networking           6:00-7:00 pm 

Main Presentation             7:00 – 8:00 pm 

Reserve your spot by filling out the Eventbrite form at the end of this announcement.

Members seeking employment are eligible for the courtesy dinner.  Be prepared to show your membership number.

Pre-meeting:

Title Human Factors and Implications for Medical Device Design

Abstract:  Human factors engineering encompasses the science and methods used to make products and services easy to use, and in the case of medical device design, safe to use.  This presentation provides an overview of human factors engineering, with examples of how evolving product designs can improve user experiences.  A quality system that is “fit for use” can only be evaluated as such when it is usable by the target population.  Usability takes on even greater importance when the system is a medical device because operator mistakes can have severe consequences.

Biography:  Ed Halpern, PhD, is a Principal Human Factors Research Engineer, focusing on medical combination products that are self-administered by patients.  He joined AbbVie in 2014 after 6 years at Baxter Healthcare, where he worked as an Engineering Specialist of Human Factors, focusing on the human factors design and evaluation of Large Volume Pumps for administering medications in hospitals and of dialysis devices for use in the home by patients suffering from kidney failure.  Prior to that, Ed spent 10 years at Motorola as Distinguished Member of Technical Staff with a focus on automatic speech recognition technologies and services and on wireless network management software tools. Prior to Motorola, Ed spent many years at Lucent Technologies/Bell Laboratories as a human factors engineer, researching and designing user interfaces for new enterprise telephone services and forward-looking technology platforms and applications.  Ed has a BS in Economics and a PhD in Instructional Systems Technology, both from Indiana University.

Main meeting:

Title: The Food Safety Modernization Act Review and Readiness

Abstract:

  • Review key parts of FSMA
  • Discuss areas of possible impact to food industry
  • Identify significant issues and questions for the future
  • Provide suggestions on how to prepare for the new regulatory environment

Biography: Loralyn (Lori) Ledenbach is a Principal Scientist in the Kraft Heinz Company Food Safety & Microbiology department, and has been with the company for over 36 years.  Over the years, Lori has worked on new method development and product category support for: salad dressings, pizza, and natural and pasteurized process cheese.  She is one of the internal process authorities for pasteurized process cheese products, and co-developed the Better Process Control School for Process Cheese standard curricula.  From 2007-2015, she was the lead for Kraft Foods global HACCP team, and now leads the newly merged Kraft Heinz Company North American HACCP team. She was an active participant in industry working groups to provide comments on the FSMA proposed rules, and was busy in 2016 conducting training sessions for the Food Safety Preventive Controls Alliance (FSPCA).  She has already trained over 140 Preventive Controls Qualified Individuals.  She graduated with a B.S. degree in Biological Sciences from Northern Illinois University and a M.S. degree in Food Science from University of Illinois.