CDRH’s 2016-2017 Strategic Priorities report makes clear they’re making internal changes that will dramatically affect devicemaker’s manufacturing and quality assurance programs. Internally, CDRH is shifting from their traditional regulatory approach, toward a model that is preventive of problems before they occur.
By September 30, 2017, CDRH intends to increase by 25% the number of CDRH staff with quality and process improvement credentials.
Plus, CDRH staff is identifying policies and practices that will encourage adoption of innovative metrics, practices, standards and evaluation tools that promote device product and manufacturing quality, and efforts to exceed baseline expectations of compliance with regulatory requirements.
This March, FDAnews — lead by industry stalwarts Steven Niedelman of King & Spalding and Elaine Messa of NSF Health Sciences — have crafted a must-attend regulatory quality intelligence gathering Congress.
Here are just a few of the many specific issues that you'll hear about when you attend the 14th Annual Medical Device Quality Congress:
- CDRH’s top strategic priorities for FY 2017
- CtQ initiative and published information documents
- MDSAP update — what to expect from an audit and how multiple sites should be audited
- What does the Trump Administration have in store for the FDA?
- European Medical Device Regulations
- MedAccred update — what has been done so far and how you can get involved
- China medical device regulatory changes including GMPs, self-inspections and trends in enforcement
- And much more — click here to see the full agenda
And you can’t miss our Pre- and Post-Conference Workshops.
You'll start out on Tuesday morning, March 28, in the invaluable workshop FDA Cybersecurity and Risk for Devices — from Software as a Device to Ransomware.
This pre-conference workshop lays out the basics of what you need to know in order to design and implement your own device cybersecurity program to help avoid FDA-483s, product liability litigation, and public embarrassment. Participants will receive a sample cybersecurity policy, a quick guide to implementing a compliant cybersecurity program, a checklist to help build your cybersecurity life-cycle program and several guidance documents.
Wrap up the three day conference on Thursday, March 30, with the full-day session, Managing & Auditing Medical Device Supplier Quality.
Devicemakers continue to recognize risk management's value in satisfying regulatory requirements and protecting against problems like today's extended supply chain. But implementing risk management is far from easy. This workshop will help you better understand GHTF guidance documents as well as teach you methods and give you tools to successfully manage a cost effective implementation. You'll receive valuable documents to take back to the office, including a process map, sample questionnaire, reevaluation form, audit checklist and more.