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News Article | November 15, 2016
Site: www.prweb.com

How Does Cybersecurity Fit in Your QMS?: The Role of Quality in Securing Medical Devices **An FDAnews Webinar** Nov. 29, 2016 — 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/cybersecurityqms How does connected medical device security fit into a QMS? Device manufacturers need to provide evidence — documents — that their risk assessment process considered both intentional and unintentional security risks to the device and addresses those risks with appropriate security controls as part of the device’s design. Manufacturers should also formally define and document security processes around security event and incident handling, security education and training, and program monitoring (e.g., security audit and assessment). Consistently operationizing these processes has been a challenge for many organizations. By including these processes in QMS, the quality, effectiveness, and efficiency of processes will be enhanced and assist in securing the connected medical devices throughout their lifecycle. Leaving security as an afterthought has caused many connected medical devices on the market today to have significant cybersecurity vulnerabilities that can be exploited to gain unauthorized access to data or directly impact patient safety. A Medical Device Security Program needs to be integrated into and be integral with the Quality Management System (QMS). The good news is, QMS already includes a risk management methodology built on ISO 14971, which has similarities with the Association for the Advancement of Medical Instrumentation (AAMI) TIR57 security risk management guidance that the FDA has recently recognized. Join Veronica Lim, William Greenrose, and Nick Sikorski of Deloitte & Touche on Nov. 29 when they discuss how a document hierarchy is structured to capture security requirements that align with regulations and industry leading practices. Register today and learn the best practices for integrating medical security processes with the organization’s QMS and the ongoing role of Quality in securing connected medical devices. Meet the Presenters: Veronica Lim, Principal, Advisory, Regulatory & Compliance, Deloitte & Touche LLP Veronica has over 26 years of experience in Life Sciences with planning and implementing information management systems that support critical business processes. She is Deloitte’s co-lead for the Medical Internet of Thing’s practice and has led several global IT initiatives in the Medical Device, Pharmaceutical, Biotech and Healthcare industries. William Greenrose, Managing Director, Advisory, Regulatory & Compliance, Deloitte & Touche LLP William has over 34 years of experience in Food and Drug Administration (FDA)-regulated industry sectors including: life sciences, pharmaceuticals, medical devices, human tissue research and biotechnology. His focus is in the areas of: regulatory, clinical, quality assurance, quality control, laboratory, research and development, manufacturing, compliance and corporate operations. Nick Sikorski, Senior Consultant, Advisory, Cyber Risk Services, Deloitte & Touche LLP Nick is the Global Portfolio and Solutions Leader for Deloitte’s Medical Internet of Things practice responsible for securing connected medical devices and additional Life Sciences products developed by medical device manufacturers. His focus is on building and assessing corporate level medical device security organizations and conducting security risk assessments at the product level to identify and provide remediations for connected medical device security threats and vulnerabilities. Webinar Details: How Does Cybersecurity Fit in Your QMS?: The Role of Quality in Securing Medical Devices **An FDAnews Webinar** Nov. 29, 2016 — 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/cybersecurityqms About FDAnews: 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.


News Article | February 17, 2017
Site: www.prweb.com

Driving a Culture of Change for Devicemakers Sponsored by Axendia **FDAnews Free Webinar** March 1, 2017 — 1:30 p.m. – 2:30 p.m. ET http://info.fdanews.com/driving-a-culture-of-change-for-devicemakers Are manufacturers looking to reduce their regulatory burden? Pay dividends in enhanced and predictable product performance? Streamline processes resulting in operational efficiencies? Reduce waste driving to lower costs and improved profitability? Industry leaders and regulators are working on the Case for Quality (CfQ) initiative to shift their focus from compliance to quality by giving greater focus and emphasis to critical-to-quality practices throughout the lifecycle of the product. How are the FDA and industry finding common ground creating a culture of quality? How is the CfQ creating a competitive marketplace for device quality? What are the market and regulatory incentives for device manufacturers? Join Sean Boyd — Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance — Francisco Vicenty — Mechanical Engineer, FDA — and Daniel R. Matlis — President, Axendia — on March 1st when they’ll discuss the effect the CfQ will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient. Register today and see how innovators are showing the industry that taking proactive approaches to quality can have significant business advantages. This webinar is made possible by PTC and Kalypso. Meet the Presenters: CAPT Sean Boyd, Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance: CAPT Sean M. Boyd serves as the Deputy Director for Regulatory Affairs in the Office of Compliance at FDA’s Center for Devices and Radiological Health (CDRH). In this capacity he is responsible for managing the Center’s quality initiatives, as well as regulatory compliance and enforcement programs for the medical device industry. He has been responsible for all aspects of medical device premarket, postmarket and compliance activities and, prior to joining the Office of Compliance in 2015, led and transformed many aspects of CDRH’s electronic product radiation control program. He is an expert in FDA’s requirements for a variety of consumer, commercial and industrial electronic products, as well as radiation-emitting medical devices. Daniel R. 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. Francisco (Cisco) Vicenty,Mechanical Engineer, US Food And Drug Administration: Cisco Vicenty is a Mechanical Engineer at US Food And Drug Administration. He is also currently the Program Manager for the Case for Quality (CfQ) within the Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. This effort is part of the CDRH strategic priorities for 2016 and 2017. This strategic priority will improve access and outcomes for patients by engaging industry, payers, providers, and patients in order to increase focus on the quality and performance of medical devices. Webinar Details: Driving a Culture of Change for Devicemakers Sponsored by Axendia **FDAnews Free Webinar** March 1, 2017 — 1:30 p.m. – 2:30 p.m. ET http://info.fdanews.com/driving-a-culture-of-change-for-devicemakers About FDAnews: 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.


News Article | December 9, 2016
Site: www.prweb.com

Manufacturers spend a lot of time and money collecting all the documents and data needed while getting ready for an inspection. But — are they really inspection-ready? Do they know the internal and external data affecting their products? Are they analyzing and acting on this data? Join expert Armin Torres — Principal Software Consultant at Qualified Data Systems — on Dec. 19 when he discusses how to make sure that the data — which has come from multiple sources — is internally consistent across the full data set and with company metrics and KPIs. After attending this 90-minute webinar manufacturers will know the answers to some of their most puzzling Quality Metrics Guidance questions including: Use data to show investigators what was done, when it was done and most importantly why it was done. Meet the Presenter: Armin Torres, Principal/Senior Software Consultant, Qualified Data Systems Armin has more than 20 years of management and engineering experience in the areas of quality assurance manufacturing, technical support, statistics, validation, in-vitro diagnostics quality and regulatory compliance, and software development within the pharmaceutical and medical device industries. Armin is also a Certified Software Quality Engineer (CQE) and certified instructor of Statistical Process Control and Design of Experiments. About FDAnews: 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.


News Article | February 17, 2017
Site: www.prweb.com

Corrective Action & Preventive Action for Medical Devices Implementing the Steps to Prevent a Warning Letter **An FDAnews Webinar** Feb. 23, 2017 — 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/capamd Do manufacturers distinguish between corrective action (CA) and preventive action (PA)? The methods share techniques and tools but they are different and have different purposes. Confusing the methods or lumping them together is a major source of problems. Join industry expert Dan O’Leary on Feb. 23 when he’ll identify the most frequently cited steps in the corrective and preventive action processes, explain the issues that warning letters reveal and provide information to avoid these problems. After this 90-minute webinar attendees will: BONUS: Participants receive a checklist designed to help implement effective corrective and preventive action systems. The checklist addresses each of the steps and includes recommendations for the procedure as well as recommendations for forms and other record keeping. Register today and implement compliant systems to withstand an FDA inspection and manage efficient and effective improvement. Meet the Presenter: Dan O’Leary is the President of Ombu Enterprises, LLC., a company offering training and execution in Operational Excellence, focused on analytic skills; and a systems approach to operations management. Dan has more than 30 years experience in quality, operations and program management in regulated industries including: aviation, defense, medical devices and clinical labs. He has a Master’s Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management. Webinar Details: Corrective Action & Preventive Action for Medical Devices Implementing the Steps to Prevent a Warning Letter **An FDAnews Webinar** Feb. 23, 2017 — 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/capamd About FDAnews: 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.


News Article | November 16, 2016
Site: www.prweb.com

Centralized Submissions Management: Planning, Tracking, Resource Management and Metrics in Real Time Sponsored by Sylogent **FDAnews Free Webinar** Dec. 1, 2016 — 1:30 p.m. – 2:30 p.m. ET http://info.fdanews.com/centralized-submissions-management What do manufacturers have on their plates? Maybe, a little bit of alphabet soup? And devicemakers have their 510(k)s, PMA, PDPs and de novo applications. That’s a lot to keep up with. And the expectation is to do more with less. And that’s next to impossible. Who wouldn’t like to get it right the first time? With no duplication? No repetition? No lost documents? Join Jack Yeager founder of Sylogent on Dec. 1 when he’ll discuss software solutions that streamline and automate core business processes saving millions of dollars through improved compliance, reduced employee workload and lower operating costs. Attendees will learn how Centralized Submission Management can benefit their organization including: Register today and discover the benefits of a centralized submission management system. Meet the Presenter: Jack Yeager, Founder of Sylogent Jack Yeager has over 25 years experience working on process automation, including a patent in 2005. His experience spans a variety of industries including manufacturing, insurance, lending and life sciences. He formed Sylogent in 2008 to focus on compliance process automation that reduces the time, effort and cost to publish required information. Jack is currently focused on streamlining the complicated, but critical, submission process. Webinar Details: Centralized Submissions Management: Planning, Tracking, Resource Management and Metrics in Real Time Sponsored by Sylogent **FDAnews Free Webinar** Dec. 1, 2016 — 1:30 p.m. – 2:30 p.m. ET http://info.fdanews.com/centralized-submissions-management About FDAnews: 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.


News Article | November 29, 2016
Site: www.prweb.com

Ensure Raw Material Quality and Finished Product Authenticity Throughout the Supply Chain Sponsored by Sparta Systems **FDAnews Free Webinar** Dec. 8, 2016 — 1:30 p.m. – 2:30 p.m. ET http://info.fdanews.com/ensure-raw-material-quality-and-finished-product-authenticity There’s growing pressure for drug manufacturers to have “end to end” visibility of their supply chains. From the FDA’s Safety and Innovation Act — including the Good Importer Guidelines — to the Drug Supply Chain Security Act, FDA officials have squarely put the onus on manufacturers to stand behind the manufacturing of their products and the distribution of them into the market. Join Bob Brooks — of Blewbury Brooks Consulting, formerly Abbvie and Abbot Global Sourcing Group — on Dec. 8 as he discusses the challenges and implications of dealing with a global supply chain and the immediate need for drug makers to become more proactive: Register today and learn what approaches to take ensure the integrity of a supply chain. Meet the Presenter: Dr. Robert Brooks has 25 years’ experience working in the Pharma and Medical Devices industry for blue chip companies under GxP regulations. His experience includes contract research and manufacturing organizations, production of finished goods, global logistics & distribution and supply chain. He has held positions in R&D, QA, Operations, Procurement and Supply Chain. Now working as an independent consultant with a principle engagement with the BioPhorum Operations Group. Webinar Details: Ensure Raw Material Quality and Finished Product Authenticity Throughout the Supply Chain Sponsored by Sparta Systems **FDAnews Free Webinar** Dec. 8, 2016 — 1:30 p.m. – 2:30 p.m. ET http://info.fdanews.com/ensure-raw-material-quality-and-finished-product-authenticity About FDAnews: 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.


News Article | February 17, 2017
Site: www.prweb.com

How to Integrate FDA Device Approval and Reimbursement **An FDAnews Webinar** Feb. 22, 2017 — 1:30 p.m. – 2:30 p.m. ET http://www.fdanews.com/deviceapproval What are the critical reimbursement questions manufacturers should be asking before selecting an FDA approval pathway? How should they evaluate the 510(k)/PMA options to get maximum reimbursement? To have a successful medical device launch regulatory affairs and product management execs need to consider reimbursement requirements throughout the FDA process. To make it even more complicated every year Medicare changes payments for hospitals, doctors, clinical lab tests and ambulatory surgical centers. The most recent reimbursement changes became effective Jan. 1, 2017. How do these changes affect devices? Join Steve Terman — Principal Attorney, Olson Frank Weeda Terman Matz — and Gordon Schatz — President, Schatz Reimbursement Strategies — on Feb. 22 when they’ll explain how to strategically blend reimbursement with FDA regulatory issues and identify the need for outcomes data, comparative evidence, professional society guidelines and how to meet Medicare and managed care reimbursement standards. After this 90-minute webinar attendees will understand: Steve Terman Esq. is one of the nation’s leading FDA lawyers who advise manufacturers on FDA medical device law, regulatory issues, and litigation matters. Steve heads up his law firm’s medical device practice. His expertise covers all areas of medical device law including: development of strategies to bring medical devices to market, pre-submission advocacy with key FDA officials, and preparation of regulatory filings; compliance with MDR requirements, employee education and system audits; classification and reclassification of medical devices; labeling, advertising, and promotion of medical devices among others. Gordon Schatz, JD, President of Schatz Reimbursement Strategies, is a nationally recognized expert in reimbursement for breakthrough medical device innovations and evolving device technologies. He has successfully obtained new product/procedure billing codes, expanded coverage, and increased payment from government and private commercial health payment programs, especially Medicare/Centers for Medicare and Medicaid Services. Webinar Details: How to Integrate FDA Device Approval and Reimbursement **An FDAnews Webinar** Feb. 22, 2017 — 1:30 p.m. – 2:30 p.m. ET http://www.fdanews.com/deviceapproval About FDAnews: 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.


Xu K.,FDA | Cote T.R.,FDA
Briefings in Bioinformatics | Year: 2011

Facing substantial obstacles to developing new therapies for rare diseases, some sponsors are looking to 'repurpose' drugs already approved for other conditions and use those therapies to treat rare diseases. In an effort to facilitate such repurposing and speed the delivery of new therapies to people who need them, we have established a new resource, the Rare Disease Repurposing Database (RDRD). The advantages of repurposed compounds include their demonstrated efficacy (in some clinical contexts), their observed toxicity profiles and their clearly described manufacturing controls. To create the RDRD, we matched the US Food and Drug Administration (FDA) orphan designation database to FDA drug and biological product approval lists. The RDRD lists 236 products that have received orphan status designation-that is, were found to be 'promising' for the treatment of a rare disease-and though not yet approved for marketing for that rare disease, they are already approved for marketing to treat some other disease or condition. The RDRD contains three tables: Orphan-designated products with at least one marketing approval for a common disease indication (N=109); orphan-designated products with at least one marketing approval for a rare disease indication (N=76); and orphan-designated products with marketing approvals for both common and rare disease indications (N=51). While the data included in the database is a re-configuration/cross-indexing of information already released by the FDA, it offers sponsors a new tool for finding special opportunities to develop niche therapies for rare disease patients. Published by Oxford University Press 2011.


News Article | November 14, 2016
Site: www.prweb.com

Effective and Efficient Medical Device Recalls: Creating Your Recall Strategy **An FDAnews Webinar** Nov. 29, 2016 — 11:00 a.m. – 12:30 p.m. ET http://www.fdanews.com/mdrecalls Lack of proper recall planning and expertise can open a company to regulatory compliance issues — hefty fines — and irreparable brand damage. Teams may be inexperienced in effectively dealing with recalls and their intricacies. Join Willie Bryant and Chris Harvey — both of Stericycle ExpertSOLUTIONS on Nov. 29 when they’ll discuss how to assess the current recall plans to see if they’ll really work when put into action. Attendees will learn the following: Manufacturers can’t afford to make mistakes during a recall. Register today and evaluate a recall plan with confidence. Meet the Presenters: Willie R. Bryant, Expert Consultant, Stericycle ExpertSOLUTIONS Mr. Bryant, a former senior recall coordinator in the FDA, is a thought-leader in the world of recalls. He helps clients navigate the increasingly complex regulatory structure and emerge with successful outcomes during potentially damaging events. Chris Harvey, Recall Strategist, Stericycle ExpertSOLUTIONS Mr. Harvey works with clients to ensure flawless implementation and customer integration throughout the entire product recall process. He assists in the scoping, plan development and recall execution for a diverse set of industries; including pharmaceutical, medical device, food & beverage and consumer products. Webinar Details: Effective and Efficient Medical Device Recalls: Creating Your Recall Strategy **An FDAnews Webinar** Nov. 29, 2016 — 11:00 a.m. – 12:30 p.m. ET http://www.fdanews.com/mdrecalls About FDAnews: 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.


News Article | November 14, 2016
Site: www.prweb.com

Inspections — From the Routine to the Truly Bizarre: How to Deal with Challenging Situations **An FDAnews Webinar** Nov. 30, 2016 — 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/inspectionsroutinetobizarre How should manufacturers respond to this situation? It’s Dec. 26 — the day after Christmas — and an investigator arrives for an unannounced inspection and is upset because personnel aren’t available. What if the investigator takes out his smart phone and begins taking pictures with no explanation? As manufacturers well know even a routine FDA inspection can be problematic, challenging and bizarre. Join storyteller and expert regulatory compliance specialist Steve Niedelman of King & Spalding on Nov. 30 when he’ll discuss these and other real-life situations. Steve has participated in hundreds of FDA inspections involving both small and large manufacturers. After attending this 90-minute webinar attendees will be able to: Register today and be prepared to deal with challenging inspection situations. Meet the Presenter: Steve Niedelman, Lead Quality Systems and Compliance Consultant, King & Spalding 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. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act. Webinar Details: Inspections — From the Routine to the Truly Bizarre: How to Deal with Challenging Situations **An FDAnews Webinar** Nov. 30, 2016 — 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/inspectionsroutinetobizarre About FDAnews: 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.

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