FDA

White Oak, MD, United States
White Oak, MD, United States
SEARCH FILTERS
Time filter
Source Type

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.


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 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 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 12, 2017
Site: www.prweb.com

Understanding and Implementing EU Medical Device Regulation **Presented by FDAnews and Ombu Enterprises** July 11-12, 2017, Cambridge, MA http://www.fdanews.com/eumdreg The EU has up-ended its device rules. The Medical Device Regulation (MDR), which replaces the existing Medical Device Directive (MDD), is packed with new provisions, changes to existing ones, inclusions and exclusions. These changes include: And this barely scratches the surface. Come to Boston July 11-12 for two intense days of: In a special workshop feature, attendees will apply the MDR’s new provisions to one of their own products that currently has the CE Mark under the MDD (especially Annex II) and satisfies the U.S. UDI rule. Workshop leader, Dan O’Leary of Ombu Enterprises LLC, is a favorite of thousands of conference attendees for his ability to simplify the most complex device-related topics. Meet the Presenter: Dan O’Leary, President, Ombu Enterprises, LLC Dan has more than 30 years’ experience in quality, operations and program management in regulated industries including, aviation, defense, medical devices and clinical labs. Dan is now President of Ombu Enterprises, LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Masters 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. Conference Details: Understanding and Implementing EU Medical Device Regulation **Presented by FDAnews and Ombu Enterprises** July 11-12, 2017, Cambridge, MA http://www.fdanews.com/eumdreg 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 11, 2017
Site: www.prweb.com

GMP Human Error Reduction Program: The Keys to Increased Performance **Presented by FDAnews and Ginette M. Collazo ** June 29-30, 2017 – Arlington, VA http://www.fdanews.com/humanerrordrugdevice Using a combination of small tweaks to manufacturing systems and subtle improvements in employee training, Ginette Collazo will help attendees cut their error rate in half or even more. One drugmaker she worked with cut baseline errors from 4.7 per thousand units to 1.9 per thousand, a 60% cut in just 10 months. Over 15 years of working with drug, device and biologics firms, Dr. Collazzo has developed a system that pays off in lower costs, greater efficiency and higher morale. Discover her techniques June 29-30 in Washington, a two-day workshop for everyone involved in drug, device and biologics manufacture. Attendees will break into small groups to brainstorm manufacturing problems taken from life. Getting to the root of root cause, understanding human behavior on the production line and, maybe most important, spotting what’s not working in the operation. Commit to slashing manufacturing error rate in half or even better. Dr. Collazzo is a leader in technical training, organizational development and human reliability. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth and Medtronic, plus many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics. Conference Details: GMP Human Error Reduction Program: The Keys to Increased Performance **Presented by FDAnews and Ginette M. Collazo ** June 29-30, 2017 – Arlington, VA http://www.fdanews.com/humanerrordrugdevice 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.


News Article | May 12, 2017
Site: www.prweb.com

Achieve a Competitive Edge Through Quality Metrics Sponsored by Dassault Systèmes BIOVIA **FDAnews Free Webinar** May30, 2017 — 11:00 a.m. – 12:00 p.m. ET http://info.fdanews.com/achieve-a-competitive-edge The goal of the revised quality metrics guidance is the collection of quality metrics data from life science companies to foster the FDA’s aim for risk-based inspection planning. How does the FDA intend to use the quality metrics data? What data are the FDA proposing is reported? Attend this webinar to learn what steps manufacturers need to take to prepare for the FDA Quality Metrics Program. By the end, attendees will: o    Keep it cost-effective o    Validate models and systems o    Balance lagging versus forward quality indicators o    Determine which metrics matter: Key Performance Indicators o    Begin with QbD o    Install continuous verification scheme o    Trend critical quality attributes and process parameters o    Establish alert and action limits Stay ahead of the curve! Register today to understand the FDA’s vision for Quality Metrics and elevate and expand existing programs with an array of data analysis solutions. Meet the Presenters: Carmen Medina, MPH, PH.D., Vice President, Technical Services, PAREXEL® CONSULTING Carmen uses 28 years of FDA experience to support an array of US and international clients in their preparations for successful pre-approval inspections and FDA GMP inspections. She was a former Commissioned Officer in the United States Public Health Service and an FDA Investigator, where she led an international group within Team Biologics and helped usher in the new medical device regulations, QSR. Over the past 28 years, she has assisted with the development, successful approval, and commercialization of hundreds of products, including some of the largest pharmaceutical and biotech brands. Daniela Jansen, PH.D, Director, Solution Marketing, Dassault Systèmes BIOVIA Daniela is Director, Solution Marketing at BIOVIA and has more than 20 years of experience in laboratory informatics and instrumentation holding various positions in Marketing and Sales Management. She is working on the strategic product positioning and customer benefits of the BIOVIA Life Science solutions and has expertise in 21 CFR Part 11 Compliance and Lean Six Sigma. Webinar Details: Achieve a Competitive Edge Through Quality Metrics Sponsored by Dassault Systèmes BIOVIA **FDAnews Free Webinar** May30, 2017 — 11:00 a.m. – 12:00 p.m. ET http://info.fdanews.com/achieve-a-competitive-edge 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 Risk Management: Batten Down the Hatches – Rough Seas Ahead **Presented by FDAnews and Ombu Enterprises** June 27-28, 2017 – Arlington, VA http://www.fdanews.com/mdriskmanagement Say “risk management” to a medical device manufacturer and watch his or her face. Risk management is just plain hard, complicated, conflicted and confusing. Yet few topics spread tentacles into so many aspects of an operation or draw so many warning letters. It’s time to batten down the hatches and come to terms with the rough seas of risk management. FDAnews and Ombu Enterprises are here to help, with a two-day workshop. These intense skull sessions are designed to untangle every mystery of risk management and put manufacturers on a path to full compliance. Attendees will discover: Plus three new sessions have been added for 2017: The workshop starts with ISO 14971:2007 as the base process standard. The first day focuses on the risk management process, using EN ISO 14971:2012, the de facto global standard. The workshop points out differences with the MDR and anticipates the European version of the standard. The second day focuses on the processes with a base in ISO 14971:2007. Many of these processes, defined in standards or guidance documents include specific, subject oriented, requirements. Dan O’Leary, a favorite presenter at dozens of FDAnews-sponsored workshops, provides the understanding and practical tools to join the disparate pieces into a coherent whole and create a solid foundation for the coming changes. Mr. O’Leary boasts 30+ years’ experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs. Risk management affects nearly every aspect of medical device manufacture. Yet many devicemakers lag behind the curve, courting warning letters or worse. Get up to speed quickly and easily. Who Will Benefit: Here are just a few of the many executives who will benefit: Conference Details: Medical Device Risk Management: Batten Down the Hatches – Rough Seas Ahead **Presented by FDAnews and Ombu Enterprises** June 27-28, 2017 – Arlington, VA http://www.fdanews.com/mdriskmanagement Tuition: Early Bird Pricing (through May 26): $1,597 After May 26: $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.

Loading FDA collaborators
Loading FDA collaborators