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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. Course [...]

A key component of our Leadership Training Series, this module serves as the foundation for establishing high performing leaders. Credibility is earned through working to gain the trust and respect of your employees each day. This module defines the relationship between trust, respect and credibility, covers the importance of follow up and honoring commitments, provides tips [...]

Who Should Attend? This workshop is designed specifically for maintenance personnel responsible for correcting non-compliance areas and for maintaining machines and equipment in a manner that will guarantee continuous compliance. This workshop will help maintenance people achieve the results that are necessary to insure continuous compliance. Of course, anyone who has any TOSHA compliance responsibility [...]

SEED 2019 will focus on advances in science, technology, applications, and related investments in the field of synthetic biology. For more info:  http://synbioconference.org/2019

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 [...]