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.
Pre-Dinner Tutorial Speaker: Fatma Ali
Presentation: The New Look of ISO 13485
History of changes:
- 2016, alignment with 21 CFR 820
- 2012, alignment with EU MDDs
- 2003 version is the official in Canada and the rest of GHTF countries.
- Medical device manufacturers use ISO 13485. Why?
- 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.
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).