As the pandemic approaches its latter stages, it has been more than a year since medical device industry leaders and executives have been able to get together in person at conferences and gatherings to share information and experiences. Opportunities to have virtual events of the same nature have been rare as well. One of those […]
On June 17-18, 2021, ISPE will be hosting a virtual conference, the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference: Sustainable Implementation of Quality Risk Management. Join leaders from industry (including Lachman’s CEO and President, Fran Zipp) and representatives from international regulators to discuss many issues related to quality risk management, with special emphasis on practical […]
Ricki A. Chase, M.S, Lachman Consultants, wrote a recent article for Contract Pharma looking at the benefits and challenges of the trend towards combination products. Here is a brief excerpt from the article: “As the life sciences industries have continued to evolve, the need for ever changing nomenclature has evolved along with it. It was […]
(Westbury, NY – March 16, 2021) Fran Zipp, President and CEO of Lachman Consultants, Inc., a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, today announced that John McShane has joined the firm as Vice President of Cell & Gene Therapy, Compliance and Business Development. In this role, McShane […]
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 […]
