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) […]
There’s still time to register for Lachman Consultants’ free webinar, “Looking Ahead: Virtual Auditing for FDA Inspection Preparedness: Right Now, Next Year and Beyond.” The event, which takes place Tuesday, December 15, 2020, from 11:00 am to 11:45 am EST, is an in-depth look at how organizations regulated by the FDA can utilize new virtual […]
The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]
On Wednesday, December 9, 2020, Fran Zipp, CEO and President of Lachman Consultants will be delivering the Opening Address during the Joint Opening Plenary Sessions of the ISPE Singapore Affiliate Virtual Conference. Joining her in the Joint Opening Plenary are Pierre Winnepenninckx, Conference Chair, ISPE Singapore Affiliate, and Shanshan Liu, President, ISPE Singapore Affiliate, as well as regulators […]
(Westbury, NY— November 2020) Fran Zipp, Past International Board Chair, ISPE and CEO of Lachman Consultants is scheduled to deliver opening remarks at the 2020 ISPE Singapore Affiliate Conference & Exhibition. The three-day virtual event featuring programs, seminars, leading-edge technology, and presentations by top industry experts will take place Wednesday, December 9th through Friday, December […]
(Westbury, NY – October 2020) Lachman Consultants Services, Inc. (Lachman Consultants), a provider of compliance, regulatory, and technical consulting services to the global pharmaceutical and related industries, has announced that it will be an active participant at the 2020 ISPE Annual Meeting and Expo, Monday, November 2nd through Friday, November 6th, 2020. Entitled “Driving the […]
New Technology Resolves On-Site Inspection Challenges Amid Pandemic (Westbury, NY – October 2020) Lachman Consultants Services, Inc. (Lachman Consultants) is introducing Virtual Touring, a state-of-the-art experience that allows manufacturing facilities to safely conduct virtual inspections, tours and visits, even in the midst of the COVID-19 pandemic. This technology is vital to the Life Sciences industry, […]
John Darby, M.Sc., Senior Director of Lachman Consultants, wrote a recent article for Contract Pharma applying the principles of Quality Risk Management to get medicines to market faster. Here is a brief excerpt from the article: “As vaccine development progresses globally to address the coronavirus pandemic, assurance of manufacturing capability to address supply needs is […]