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 [...]
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 [...]
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) [...]
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, [...]