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The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – September 9-13, 2019 in Ireland

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 [...]

2019-09-05T18:28:57+00:00September 5th, 2019|

Manufacturing Leadership Development Series – Module 1: Trust, Respect and Credibility – September 3, 2019 – 9 am to 12 noon ET

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 [...]

2019-08-28T18:46:58+00:00August 28th, 2019|

Maintenance Related TOSHA Compliance Workshop – August 27, 8:30 am to 4 pm at the Kingsport Chamber, 400 Clinchfield Street, Kingsport, TN

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 [...]

2019-08-12T20:09:44+00:00August 12th, 2019|

Phone Service Disruption

Focus is currently experiencing a phone service disruption. Please use email or individual cell numbers to contact Focus personnel until service is restored.

2019-07-15T18:20:23+00:00July 15th, 2019|

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – June 24-28, 2019 in Arlington, VA

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 [...]

2019-06-18T18:01:51+00:00June 18th, 2019|

Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings – June 20-21, 2019 in Philadelphia, PA

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 [...]

2019-06-13T18:23:02+00:00June 13th, 2019|

Webinar: CDER/CBER – Identification of Medicinal Products Initiative – June 13, 2019 – 1:00 pm to 2:30 pm ET

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 [...]

2019-06-12T18:30:44+00:00June 12th, 2019|

Knoxville Chamber of Commerce – Shrimp Boil 2019 – June 13, 5 to 7 pm

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

2019-06-07T13:48:30+00:00June 7th, 2019|