Falls Church, VA (PRWEB) June 10, 2014
FDAnews is pleased to announce that Steven Silverman, Director, Office of Compliance, CDRH, FDA has been selected to present the keynote address at the 11th Annual Medical Device Quality Congress.
As the Director of CDRH’s Office of Compliance Mr. Silverman oversees a staff of more than 170 regulatory and scientific personnel who assure compliance with the medical-device related provisions of the FDCA.
Mr. Silverman will present the FDA’s Case for Quality Initiative Update. He will explain how reviewing and explaining often-cited 483 violations is not the only way to achieve device quality by presenting FDA device quality-related initiatives that move beyond the inspect-and-cite regulatory model.
Attendees will have a chance to ask questions directly about:
- How the Case for Quality Initiative works and how to benefit from it
- About emerging FDA initiatives that similarly focus on device quality, enhanced transparency and stakeholder engagement
- The impact of the Office of Compliance reorganization
For 2014, FDAnews has crafted a three-day agenda that will address the most importation quality and compliance challenges confronting devicemakers. Attendees will walk away with actionable information and insights that can be applied immediately.
Register now with the confidence that attendees will learn how to improve their quality systems, relying on tightly focused sessions led by industry experts and FDA officials. These presentations will feature detailed case studies and interactive panels; attendees are sure to gain fresh ideas and tips that they'll be able to take back to their company.
And one thing's for sure: attendees will leave the Congress with a Big Five FixTM, the knowledge and the actionable items needed to address any Big Five quality concerns and improve quality systems.
Here's just a sample of specific issues that attendees will hear about while attending MDQC 2014:
- How pushing quality management down to the plant and site level — vs. centralized quality management — lends itself to greater compliance improvements.
- How to review the implementation, effectiveness and completion of the CAPA file prior to closing.
- How the 5 top concerns of supplier risk management (product risk, business risk, recalls risk and liability risk) are linked and how to assure that internal SOPs and processes cover them all.
- How to choose whether to use the FDA’s eSubmitter system or HL7 solutions for eMDR — each come with pros and cons and could impact compliance with the FDA’s Aug. 2015 deadline.
- Best practices for identifying and addressing product failures, including how to preemptively position a company as transparent and compassionate while minimizing the appearance of negligence in the face of product liability litigation.
- And much, much more.
With so much to stay current on, it's a real challenge to be a device or diagnostics professional today.
Who Will Benefit:
- Quality Assurance/Quality Control
- Manufacturing and Contracting
- Supply Chain Management
- Risk Management and Product Lifecycle Management
- Executive Management
- Regulatory Affairs
- Research and Development
- Compliance Officers
- Consultants/Service Providers
Meet the Co-Chairpersons:
Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the FDA.
Elaine Messa is Executive Vice President at NSF Health Sciences. She has more than 30 years of experience in FDA regulation of medical devices, having focused on the development and implementation of compliant quality systems for medical devices in the United States.
11th Annual Medical Device Quality Congress:
Managing the “Big Five” Quality Concerns
**Presented by FDAnews**
June 24-26, 2014 – Bethesda, MD
Conference Only: $1,697
Additional pricing options are available online. Plus, team discounts if you send two or more.
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.