The week of February 1, 2021, Lachman Consultants held their inaugural Medical Device Week: A Lachman Learning Experience™. The week combined blogs and a webinar that touched on several different topics involving AI and diagnostics, data governance, SDLC infrastructure, change control, cybersecurity, as well as organizational maturity. Despite the name of the week, many of […]
Medical Device Week, a Lachman Learning Experience™ provided a great opportunity for industry professionals to gain knowledge and insight into a range of topics critical to the medical device industry. Our initial feedback indicates that those who participated found it valuable and highly informative. One of the most important topics covered was the FDA’s focus […]
Next Wednesday’s free webinar from Lachman, “FDA Incentivizing Organizational Maturity to Drive Product Quality,” will be hosted by Lachman’s Vizma Carver, M.S. In this 90-minute session, she will dive in on the FDAs efforts to utilize incentives to drive product quality. As someone who used to work at the FDA, Ms. Carver is uniquely positioned […]
The FDA is focused on evolving the medical device industry, ensuring safety, and enhancing quality among all manufacturers. Their goals are being met in part through two incentive programs – the Center for Devices and Radiological Health’s (CDRH) Case for Quality Voluntary Improvement Program (CFQ VIP) and the Center for Drug and Evaluation Research’s (CDER) […]
In 2019, FDA issued the first Warning Letter for violations of the Drug Supply Chain Security Act, signaling its heightened attention to supply chain and distribution issues. Since DSCSA was enacted in 2013, various provision have come into effect. It is important for companies not just to understand the law’s requirements, but also how to […]
On Tuesday, July 21, Mary Oates, Ph.D., Vice President, Compliance Services, will be participating in a webinar organized by Informa, publishers of the Pink Sheet and Scrip. Mary will be a panelist in a session on Virtual Drug Inspections, occurring at 2 PM EST. The entire webinar series, which is taking place over a 24 […]