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This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. For [...]

Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and [...]

FDA subject matter experts will introduce the Identification of Medicinal Products (IDMP) initiative, scope, and benefits. They will also discuss FDA’s approach and challenges with the adoption of the five International Organization for Standardization (ISO) standards. The goals, objectives and timeframe for the development and implementation of the Global Substance Registration System’s (G-SRS) will also [...]

The Shrimp Boil will feature great food, music, and top business and community leaders.  Elected officials and others from across Tennessee have been invited to this extraordinary affair. Casual attire is encouraged! Location:  Jackson Terminal, 213 W. Jackson Avenue, Knoxville Cost:  $35 for members, $45 for non-members Purchase your tickets at eventbrite.com https://www.eventbrite.com/e/shrimp-boil-2019-tickets-53026144626

Learn about FDA economic assistance and economic incentives so you may maximize potential benefits. Economic assistance is available in the pre-approval period of drug development for the conduct of clinical trials.  Economic incentives are granted post-approval to reward innovation in drug development. For more info:  https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/regulatory-education-industry-redi-webinar-financial-incentives-cder-medical-products-june-10-2019

AAMI has changed the name of its premier health technology event from the AAMI Annual Conference & Expo to the AAMI Exchange. The new name and brand promise reflect the Association's commitment to connect the full gamut of AAMI stakeholders—biomedical and clinical engineers, technicians, cybersecurity and sterilization experts, and hospital administrators and managers and the [...]

CDER and CDRH invite you to interact with and learn directly from FDA’s regulatory experts. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. Attendees will leave with a set of tools to assist in preparing regulatory filings and interacting with the [...]

Presented by the Society for Biological Engineering (SBE), this conference will bring together leaders and trainees from cutting edge fields of bioengineering and nanotechnology. Topics to be presented include: biomolecular engineering, translational medicine, cell engineering, immunoengineering, and mechanobiology. The global objective of the conference is to bring to the forefront truly transformational development in bionanotechnology. For [...]

Building Safety Month is an international campaign that takes place in May to raise awareness about building safety. This campaign reinforces the need for the adoption of modern, regularly-updated building codes, and helps individuals, families and businesses understand what it takes to create safe and sustainable structures. The International Code Council, its 64,000 members, and [...]

For more than 50 years, the President of the United States has issued a proclamation announcing National Small Business Week, which recognizes the critical contributions of America’s entrepreneurs and small business owners. More than half of Americans either own or work for a small business, and they create about two out of every three new [...]