Yearly Archives: 2019

This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be [...]

This 2.5-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System regulation and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation [...]

For registration info:  https://www.aami.org/events/eventdetail.aspx?ItemNumber=7186

This event offers practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) assessment process. FDA will also discuss science unique to generic drug applications. After this course, attendees will be able to: Discuss requirements for an ANDA Understand and determine when to use a reference listed drug or a [...]

Tennessee Gov. Bill Lee announced today that Tennessee's Severe Weather Awareness Week is Feb. 24 to March 2, 2019, and the Tennessee Emergency Management Agency (TEMA), Tennessee Association of Broadcasters (TAB), and the National Weather Service (NWS) are asking Tennesseans to make severe weather planning and preparedness a priority. “Severe weather, natural disasters, and man-made [...]

DA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in [...]

Presented by the Society for Biological Engineering (SBE), the 8th International Conference on Bioengineering and Nanotechnology 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 [...]

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 [...]

Skywatchers across the continental U.S. will be treated to a total lunar eclipse overnight on Jan. 20-21, when Earth's shadow sweeps over the lunar surface to give it a reddish tinge and turn it into what some call a "blood moon." This will be the first lunar eclipse of 2019 and the last total lunar eclipse until [...]