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News Article | May 10, 2017
Site: www.prweb.com

Chances are manufacturers have negotiated many a supply contract. Some have worked out well and some probably have not. So what can be done to boost the success rate? Sign up now for Supplier Contracts for Non-Lawyers, a standout new webinar from FDAnews. No legalistic jargon here. Presenter Courtney Stevens Esq. specializes in the plain-English approach. In just 90 breakneck minutes, she’ll spell out: Bonus! Negotiations checklist for every aspect of the contract negotiation process. With lawyers charging three figures per hour (or four!), contract goofs can be costly going in and ruinous down the road. Don’t let a badly drawn contract expose the company to perhaps millions of dollars in judgments, penalties and legal fees. Meet the Presenter: Courtney Stevens Esq. is senior attorney-risk management and loss control, MedMarc Insurance Group, where she specializes in product liability avoidance and negotiates (and sometimes re-negotiates) contracts. She is a frequently published author on product liability risk management and blogs on product liability in the life sciences. Webinar Details: Supplier Contracts for Non-Lawyers: What Really Needs to be in Your Agreements **An FDAnews Webinar** May 23, 2017 — 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/suppliercontracts 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 | May 9, 2017
Site: www.prweb.com

Medical device users complain. Manufacturers respond. But that’s not the end of the story. Mastering complaint reporting takes effort and attention. Guidance would be welcome. So here’s a timely new webinar from FDAnews to answer all complaint-reporting questions. In just 90 information-packed minutes, Dan O’Leary of Ombu Enterprises LLC clarifies complex and confusing rules and formats that govern device complaint reporting. Attendees will discover: Bonus Material! Participants receive a technical description of analysis methods plus guidance on their use. Complaint management is essential to a functioning quality management system. Understanding the FDA’s QSR isn’t enough; manufacturers must also master ISO 13485:2016 and the new EU-MDR. Meet the Presenter: Dan O’Leary, a favorite presenter [link to testimonials box] at dozens of FDAnews-sponsored workshops. Mr. O’Leary boasts 30+ years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. His consultancy, Ombu Enterprises LLC, focuses on operational excellence and regulatory compliance particularly for small manufacturing companies. He 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. Who Will Benefit: People in the following roles can especially benefit from this presentation: 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 | May 16, 2017
Site: www.prweb.com

When Britain exits the EU, what happens? Will the EMA stay in London? What happens with the Unified Patient Court? The Brexit is about to happen. Manufacturers need answers before that happens. Get a look into the Brexit future. Mark the calendar for a standout webinar presentation on Wednesday, May 31 with a lawyer who specializes in the global drug and device business. Michael Burke Esq., Partner, Arnall Golden Gregory LLP is his firm’s in-house expert on drugs and devices as well as a specialist in cross-border international trade. His particular focus, Ireland, is the one remaining English-speaking nation in a post-Brexit EU. Mr. Burke counsels transnational drug and device clients on trade issues including anti-boycott regulations, export controls, economic sanctions and the Foreign Corrupt Practices Act, to mention just a few. In 90 intense minutes, he’ll answer the following questions and more: Meet the Presenter: Michael Burke Esq., Partner, Arnall Golden Gregory LLP Washington lawyer Michael Burke has dual qualifications as a guide to the post-Brexit world: He is his firm’s in-house expert on drugs and devices; and a specialist in cross-border international trade. His particular focus, Ireland, is the one remaining English-speaking nation in a post-Brexit EU. Mr. Burke counsels transnational clients on anti-boycott regulations, export controls, economic sanctions and the Foreign Corrupt Practices Act; and represents them before the Justice Dept., Treasury Office of Foreign Assets Control, State Dept. Office of Defense Trade Controls and Commerce Dept. Bureau of Industry and Security. He is author of the Irish Export Insights blog, https://irishexportinsights.com/, and co-editor and co-author of The Corporate Counsel’s Guide to Doing Business in China (Thomson Reuters). Who Will Benefit: This top-level Web presentation is aimed at senior officials: President, Vice President, CEO/COO/CFO as well as executives with responsibilities in: 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 | May 18, 2017
Site: www.prweb.com

A trail being blazed by provisions of the 21st Century Cures Act and proposed Medical Device User Fee Amendments (MDUFA) IV goals not to mention a business-friendly White House promise to decrease premarket-approval costs and speed new products to commercialization. All devicemakers have to do is figure it all out. FDAnews is here to help. Mark the calendar for Wednesday, June 7, and the Medical Device Premarket Regulatory Pathways webinar when two NSF Health Sciences senior consultants guide manufacturers down this new path to speedier premarket approvals. Attendees will discover: The presenters boast a wealth of premarket-approval experience. Caroline Rhim Ph.D. was Branch Chief-Anterior Spinal Devices, Office of Device Evaluation, CDRH, with deep experience involving premarket submission of novel orthopedic and cardiovascular devices. Meaghan Bailey RAC is an expert on preparing sponsors for Medical Devices Advisory Committee meetings and other premarket FDA interactions, and has been involved with premarket approval of in vitro diagnostics, and devices to treat and manage women’s health and diabetes. Greater profits, lower costs and speedier premarket approvals await the devicemaker who figures out these new advantages early on. 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 | May 22, 2017
Site: www.prweb.com

Medical Devices: Making the Right Choice — Your Case for Quality Sponsored by Novartis and Tech-Clarity **FDAnews Free Webinar** June 8, 2017 — 11:00 a.m. – 12:00 p.m. ET http://info.fdanews.com/md-making-the-right-choice The Case for Quality allows firms to determine how products are performing in real-world scenarios during all three lifecycle stages — premarket, production and post-production. By developing metrics across the total product lifecycle, companies will be able to better assess their critical quality practices. Failure to adhere to FDA, EU, and other standards and regulations can lead to embarrassing and costly product recalls. The Case for Quality and compliance is critical. Join Mark Turner, Technical Manager for Development IT at Novartis and Michelle Boucher, Vice President for Research at Tech-Clarity on June 8 for a discussion on current industry trends including: Meet the Presenters: Mark Turner, Service Delivery Manager, Engineering, Novartis/Alcon Mark Turner has worked at Alcon Laboratories, Inc. for 8 years. Alcon is a subsidiary of Novartis, a global healthcare company providing solutions to address the evolving needs of patients worldwide. Alcon offers a wide spectrum of eye care products. They provide innovative products that enhance quality of life by helping people worldwide see better. Mark is currently the Service Delivery Manager for Engineering and based in the Dallas/Fort Worth, supporting a Part 11 FDA Compliant Product Lifecycle Management Global Solution. His responsibilities include quality management, product analytics, and CM2 process for a full design control implementation. Michelle Boucher, Vice President for Research, Tech-Clarity Michelle has spent over 20 years in various roles in engineering, marketing, management, and as an analyst. She has broad experience with topics such as product design, simulation, systems engineering, mechatronics, embedded systems, PCB design, improving product performance, process improvement and mass customization. Michelle is an experienced researcher and author and has benchmarked over 7000 product development professionals and published over 90 reports on product development best practices. She focuses on helping companies manage the complexity of today’s products, markets, design environments, and value chains to achieve higher profitability. Webinar Details: Medical Devices: Making the Right Choice — Your Case for Quality Sponsored by Novartis and Tech-Clarity **FDAnews Free Webinar** June 8, 2017 — 11:00 a.m. – 12:00 p.m. ET http://info.fdanews.com/md-making-the-right-choice 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 | May 23, 2017
Site: www.prweb.com

User fees affect drug pricing and competition at every level. And make no mistake user fees are set to rise. Flags are flying from the FDA, where a new chief, Dr. Scott Gottlieb, is soon taking charge, to the White House, where many major decisions remain on hold, to Congress where as usual anything can happen. How much will user fees rise? How will drug policies be affected? And what will it all mean to business? Drugmakers need clarity. Not when it’s too late to protect their interests ... but now. Mark the calendar for Tuesday, June 13, when two well-placed insiders share insights, make forecasts, and help drugmakers deal with a fast-changing Washington landscape. Attendees will gain understanding of: The guides are Alex Brill, policy director and chief economist to the House Committee on Ways and Means Committee during the Bush II years and former FDAer Nancy Bradish Myers Esq., a Washington lawyer with deep expertise in health care law, regulation, policy development, government relations and strategic positioning. The Washington landscape is shifting. Discover what drugmakers need to know to stay competitive. Meet the Presenters: Alex Brill, CEO, Matrix Global Advisors. Prior to entering the private sector, Mr. Brill served as policy director and chief economist to the House Committee on Ways and Means Committee during the Bush II years, helping develop policy on taxes, health, pension, and trade. Previously he served at the White House Council of Economic Advisers. He is a Research Fellow at the American Enterprise Institute. Nancy Bradish Myers, President, Catalyst Healthcare Consulting Inc., is a Washington-based attorney with deep expertise in health care law, regulation, policy development, government relations and strategic positioning. She previously held senior roles at the FDA, on Capitol Hill, at several trade associations and with investors. 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 | May 17, 2017
Site: www.prweb.com

Best Practices in Food Process Labeling & Regulation: Pathway to Transparency or Claim Substantiation Nightmare? **An FDAnews Webinar** June 6, 2017 — 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/food When is a food “natural”, “cage free”, “humane” or “organic”? How far can a health claim go? Does “country of origin” apply to every ingredient? When is it OK to claim non-GMO, when not? What does “minimally processed” mean? What about fair trade and farm labor? What about environmental assertions? Welcome to the new world of ‘process labeling’. It’s a long way from the days when food labels were simple lists of nutrients and ingredients. GMO labeling is now mandatory, and regulators from the FDA, USDA, FTC, state and local health departments all are getting in on the food claims act. Mark the calendar for a webinar to bring manufacturers up to speed on GMO labeling, consumer safeguards, false claims and more. The presenter is Steve Armstrong Esq., former Chief Food Law Counsel at Campbell Soup Co. and now an independent advisor for EAS Consulting Group. At Campbell, Armstrong led the effort to brief FDA and USDA on Campbell’s call for mandatory GMO labeling and its research on GMO labeling and consumer acceptance. In just 90 fast-paced minutes, attendees will come away understanding: From the front page to the food section, nutrition and health are in the headlines every day. Discover how to make prudent claims that boost sales without crossing the line. Steve Armstrong, formerly the Chief Food Law Counsel for Campbell Soup Company, is an independent advisor for EAS Consulting Group. As counsel to Campbell, Armstrong led the effort to brief FDA and USDA on Campbell’s call for mandatory GMO labeling and its research about the labeling elements that give consumers clarity and the right amount of information about the use of GMOs in their foods. Webinar Details: Best Practices in Food Process Labeling & Regulation: Pathway to Transparency or Claim Substantiation Nightmare? **An FDAnews Webinar** June 6, 2017 — 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/food 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 | May 8, 2017
Site: www.prweb.com

The FDA Under a New Commissioner **An FDAnews Webinar** May 17, 2017 — 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/newcommissioner                 It’s Donald Trump’s FDA now. How will that affect manufacturers? With former FDAer Scott Gottlieb at the helm, will the agency: Mark the calendar for Wednesday, May 17, when three leading FDA analysts divine the future for every FDA-regulated business: Attendees will discover Trump-Gottlieb administration priorities, both announced and unannounced ... learn what changes manufacturers must make starting now to achieve goals for 2017 and beyond ... get advance warning of day-to-day changes likely to take place at the agency ... and come away with specific, practical guidance based on Commissioner Gottlieb’s present and past positions. For drugs, biologics, devices, clinical trials or another FDA-regulated industry, change is a certainty. The Trump-Gottlieb FDA will shape business for years to come. Don’t get caught short. Gain the insights before the changes start rolling out. Webinar Details: The FDA Under a New Commissioner **An FDAnews Webinar** May 17, 2017 — 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/newcommissioner 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 | May 5, 2017
Site: www.prweb.com

Combination Products Regulation, Policy & Best Practices: It’s a Whole New Ballgame — Are You All In? **Presented by FDAnews** June 8, 2017, Washington, DC http://www.fdanews.com/comboregs Combination products are streaming to market just as Washington makes the game tougher to play. Manufacturers need to be on top of: It’s a lot to know and a lot to comply with. Before leaping forward with combination products, manufacturers need to get up to speed. Plan now to attend FDAnews’s first-ever all-day conference on combination products featuring 17 experts from every background — drugs, devices, biologics, generics, regulatory, legal, consulting and more. Attendees will be able to: Attendees will come away with a regulatory survival strategies including safety reporting and cGMP, advertising and marketing in the combination-products era, how to submit combination products directly to the CDRH and much more. Attend this all-day Washington event in person if possible — the networking opportunities alone justify the time and expense. If not the entire conference is being livestreamed at registration savings of $50. The combination-products train is leaving the station. Get on board with this full-day working session featuring 17 speakers including top regulatory lawyers, industry execs and knowledgeable consultants, and covering all the bases. Time is short though. Conference Details: Combination Products Regulation, Policy & Best Practices: It’s a Whole New Ballgame — Are You All In? **Presented by FDAnews** June 8, 2017, Washington, DC http://www.fdanews.com/comboregs 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 | May 8, 2017
Site: www.prweb.com

Medical Device Supplier Quality Management: Are You and Your Suppliers Compliant? **Presented by FDAnews** June 21-22, 2017 – Arlington, VA http://www.fdanews.com/mdsupplierqualitymanagement Creating a robust supplier quality management and control operation is not for the faint of heart. It’s critical for companies to comply with the regulatory bodies they face. It’s also very complicated. But here’s how FDAnews can help. Noted quality expert Jim Shore (with co-author John A. Freije) has literally written the book on supplier management. The book, Proactive Supplier Management in the Medical Device Industry (2016: Quality Press), sets forth a new approach to supplier quality management. On June 20-21, Shore will teach its precepts and methods in a standout workshop available only from FDAnews. Attendees will discover better ways to: The book, which attendees will take home, is 100 pages chock full of charts, graphs and real world advice on how to create this very complicated operation. Whether new to this or an experienced hand attendees will find something of value. This interactive two-day workshop features learning by doing. Attendees take part in small-group exercises that put theory into practice, discover problems colleagues face and join with them in working out solutions. Meet the Presenter: James B. Shore, Director of Quality, Titan Medical Inc. Mr. Shore is co-author (with John A. Freije) of Proactive Supplier Management in the Medical Device Industry (2016: Quality Press). He boasts 25 years of quality and supplier management experience in medical devices, semiconductor, aerospace and defense for firms and organizations including Nypro Healthcare, Boston Scientific, Aspect Medical, Brooks Automation, Raytheon and the American College of Medical Informatics (ACMI). He is Six Sigma Black Belt and Quality Manager/Operations Excellence-certified by the American Society for Quality (ASQ), as well as an ASQ-certified Quality Auditor and Mechanical Inspector. A veteran of Operation Desert Storm, he served in the U.S. Marine Corps for more than 15 years. All book sale profits are donated to organizations that support military veterans. Conference Details: Medical Device Supplier Quality Management: Are You and Your Suppliers Compliant? **Presented by FDAnews** June 21-22, 2017 – Arlington, VA http://www.fdanews.com/mdsupplierqualitymanagement Tuition: Early Bird Pricing (through May 19): $1,597 After May 19: $1,797 Significant team discounts are available. 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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