January 19th Professional Development Dinner Meeting

Ben Moyer Image 

Post-Dinner Keynote Speaker:  Benjamin Moyer, Quality Manager, Oceaneering

Presentation:  Leading Proactive Quality
Mr. Moyer will present the tangible gains achieved in business performance and customer satisfaction as a result of implementing a proactive Quality Management System in an Oil and Gas Services Organization. The presentation chronicles the organization's journey from an inspection-based approach to a proactive, process based approach.  Results achieved in both rental and manufacturing areas within the organization are discussed.  The specific leadership behaviors and tools used to drive the needed changes provided by the quality leadership team are also explained.  Finally, the quantified gains in business performance and customer satisfaction resulting from the improvements are shared in the conclusion of the presentation, contrasting current and past states.

Fatma Ali Image 

Pre-Dinner Tutorial Speaker:  Fatma Ali

Presentation: The New Look of ISO 13485

History of changes:

  1. 2016, alignment with 21 CFR 820
  2. 2012, alignment with EU MDDs
  3. 2003 version is the official in Canada and the rest of GHTF countries.
  4. Medical device manufacturers use ISO 13485. Why?
  5. Transitioning time

Overview of the new changes:

- Maintaining effectiveness, continuing suitability and adequacy of the management system (little and very careful changes)

- Standard risk management using ISO 14971

- Tight control on supply chain

- Importance of identification and traceability

- Control of documents and records

- Software validation (when used in QMS and processes)

- Statistically and scientifically sound sampling plans

- Preventive action won’t go away

- Robust design and rigorous testing

- End use focus along with customer satisfaction

- Postmarket surveillance/Continue monitoring product usability (usability standard)

- Multiple audits (Notified Body, Competent Authority, Regulators, Customers, Hospitals and other Organizations)

Closing remarks:  DNV GL services and accreditation for ISO 13485 and MDD certification.

 

Schedule:

5:00 - 7:00pm Registration

5:30 - 6:30pm Pre-dinner Tutorial Presentation(s)

6:30 - 7:00pm Dinner

7:00 - 7:15pm Announcements

7:15 - 8:30pm Post-Dinner Main Presentation

 

Dinner Menu (catered by Demeris Bar-B-Q):  

Entree 1:  Charcoal-Grilled Vegetable Kabob

Entree 2:  Beef and Chicken Breast Meal (includes sauce, beans, potato salad, french bread, pickles, onions, and jalapenos)

Dessert:  Peach Cobbler

Decaf Coffee, Iced-Tea

 

As always, our monthly Professional Development Dinner meetings are open to the public and are no charge.  There is no requirement to be an ASQ member to attend, or to purchase a meal.  Online pre-registration closes on Tuesdays at 11:45pm before the event.  If you choose to purchase a meal at the event, the price will be $25 (only $5 more).

Speaker Keynote Speaker: Benjamin Moyer
Benjamin Moyer is Quality Manager for Oceaneering International, Inc. in Houston.  Mr. Moyer joined Oceaneering in 2011 after 10 years in various engineering and leadership roles in the Material Handling and Oil & Gas industries.  He earned his BSME from Grove City College in 2001 and is a PMI-certified Project ...

Benjamin Moyer is Quality Manager for Oceaneering International, Inc. in Houston.  Mr. Moyer joined Oceaneering in 2011 after 10 years in various engineering and leadership roles in the Material Handling and Oil & Gas industries.  He earned his BSME from Grove City College in 2001 and is a PMI-certified Project Management Professional (PMP) and an ASQ-certified Manager of Quality / Organizational Excellence (CMQ/OE) from ASQ.  Ben resides in Houston with his wife and three children.


 

Full Description
Speaker Tutorial Speaker: Fatma Ali
For the past 30 years, Fatma Ali has served Electrical Engineering, Quality Management Systems of Oil and Gas, Electronics, Research Equipment and Medical Device.  For the past 12 years, her focus was concentrated in developing quality management systems for class I, II and II medical devices.  As a Director of ...

For the past 30 years, Fatma Ali has served Electrical Engineering, Quality Management Systems of Oil and Gas, Electronics, Research Equipment and Medical Device.  For the past 12 years, her focus was concentrated in developing quality management systems for class I, II and II medical devices.  As a Director of Quality and Regulatory, she submitted successful 510Ks to the FDA and CE Mark approval to the several Notified Bodies.  She served different type of medical devices such as cochlear implants, cardiovascular catheters, patient temperature management devices, software and infusion pumps.


Her knowledge of standards and regulations made her the quality and regulatory advisor for new product development. This led her to start her own company FMA consulting, LLC in 2012 to help start-up companies evaluating their quality systems for the readiness of ISO 13485 certification and product submissions.  Besides being an ASQ CQA and CQM/OE certified, she obtained her Exemplar Global certification for Lead Auditing for ISO 13485:2016 and ISO 9001:2015.


Last year, she joined The Notified Body, DNV GL, accredited DNV GL- Nemko (Presafe) as a 13485/MDD Auditor. Her passion for safety and efficacy of medical device drives her steps to building a higher quality and compliant medical devices.


 

Full Description
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Organizer Donna O'Kelley

When?

Thu, Jan. 19, 2017
5 p.m. - 8:30 p.m.
(GMT-0500) US/Central

Event has ended

Where?

United Way of Greater Houston
50 Waugh Drive
Houston, TX 77007