Falls Church, VA (PRWEB) April 11, 2017
Reduce Supplier Costs, Rework and More While Improving Quality
Case Study: How PLM Systems Can Amp up Quality Initiatives and Boost Compliance
Sponsored by Axendia
**FDAnews Free Webinar**
April 27, 2017 — 1:30 p.m. – 2:30 p.m. ET
Every device manufactured is the result of 1,000s or more prior decisions and processes. And each of those decisions and processes needs to be documented. Not to mention be indexed, stored and ready for review at a moment’s notice.
From the minute engineers have a new idea; manufacturers start down a path of potential complexity. A journey of balancing costs, quality, safety, regulatory compliance and profit. This was the case at one major medical technology company.
Innovative companies, like the one featured in the case study, are achieving accelerated device development with integrated Product Lifecycle Management (PLM) platforms. Streamline processes resulting in improved product quality and operational efficiencies.
On April 27th, some proven ideas on how to not only manufacture products more efficiently, but more importantly boost product quality, increase innovation, speed time to market and improve patient safety will presented in a 60-minute webinar.
PLM, properly executed, builds a culture of innovation and quality. Not just baseline quality, but enhanced quality.
Join David Wolf, Program Director, Medical Device Strategy, PTC, Dave Hadfield, Senior Manager, Kalypso and Daniel Matlis, President, Axendia on April 27th from 12:30-1:30 PM EDT when they’ll discuss how focusing on quality pays dividends for devicemakers.
In 60-minutes attendees will learn more about PLM and how innovative companies are using it to:
- Accelerate product innovation
- Manage risk to drive the safety and quality of products and processes through QMS per ISO 13485:2016
- Improve the measurement of quality metrics and head off problems before they start
- Lower total quality cost, improve budgeting and accelerate profits
- Shift the focus from meeting regs to building quality into the processes
- Jump ahead of the FDA and EU drives for quality
- Achieve a preventative manufacturing model with an agreed risk-benefit framework
- Improve sales and reimbursement when and prove to regulatory agencies that quality made devices improve patient outcomes
Register today and see how innovative companies using PLM are significantly business advantages.
Meet the Presenters:
David Wolf, Program Director, Medical Device Strategy, PTC
Prior to joining PTC, David worked for medical device manufacturing companies in a variety of roles. He has designed, patented and released several product lines for worldwide distribution. David has hands on expertise in product development, manufacturing, supply chain, regulatory and quality management. He was a catalyst that drove and managed the PTC Medical Device Suite and Validation Packages, which significantly reduces the implementation time and cost for mid-market companies.
Dave Hadfield, Senior Manager, Kalypso
For the past 18 years, Dave has focused entirely in the medical device industry and has helped define the product lifecycle strategy for multiple top 20 medical device companies. Dave works with medical device clients to drive innovation, mitigate quality/safety problems and litigation risk, improve operational efficiency, reduce costs and enable compliance with regulations such as part 820 as well as ISO 13485 & 14971 standards.
Daniel Matlis, President, Axendia
Daniel R. Matlis is founder and president of Axendia, an analyst firm providing trusted advice to Life-Science and Healthcare Executives on Business, Technology and Regulatory matters. Dan has over 25 years of experience in the Industry spanning the entire value chain. He is an active member in FDA’s Case for Quality Initiative and has presented Axendia’s research findings to industry executives and the FDA.
Who Will Benefit:
- Quality affairs
- Quality control
- Product lifecycle managers
- Design and manufacturing management
- Project leaders
- Risk managers
- Metrics data managers
- Regulatory affairs
- IT professionals
FDA Quality Metrics Survival Guide
How Mid-Sized Pharma Companies Can Prepare
Sponsored by Sparta
**FDAnews Free Webinar**
March 30, 2017 — 1:30 p.m. – 2:30 p.m. ET
Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.