25
Feb

Wrapping Up Medical Device Week

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 […]

Read More
11
Feb

LACHMAN’S MEDICAL DEVICE WEEK REVISITED

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 […]

Read More
26
Jan

Webinar on FDA Incentives Features Compliance Expert

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 […]

Read More
22
Jan

MEDICAL DEVICE WEEK – A LACHMAN LEARNING EXPERIENCE – FEATURES WEBINAR ON FDA QUALITY INCENTIVE PROGRAMS

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) […]

Read More
04
Aug

Webinar: Drug Supply Chain Security Act: Legal Overview and Cross-Enterprise Compliance Strategies (August 11, 2020 @1:00-2:00 PM ET)

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 […]

Read More
17
Jul

Mary Oates to Participate in Webinar on Virtual Inspections

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 […]

Read More