“What happens if I don’t respond to my FDA-483 within 15 days?” If you find yourself asking this question, you will need a roadmap. There are steps to take to ensure you don’t miss the deadline, and details that you might need help with. The plan for responding to an FDA form 483 may follow […]
Whether you’ve been through an FDA inspection before or not, it’s highly recommended that you and your organization prepare for their visit sometime in the not-too-distant future. But despite your best efforts, it’s a very distinct probability that you will receive some inspectional observations. While conduct during an inspection is very important, your behavior post-inspection, […]
Whether you’ve been through an FDA inspection before or not, it’s highly recommended that you and your organization prepare for their visit sometime in the not-too-distant future. But despite your best efforts, it’s a very distinct probability that you will receive some inspectional observations. While conduct during an inspection is very important, your behavior post-inspection, […]
(Westbury, NY— April 2019) Lachman Consultant Services, Inc. (Lachman Consultants) will be launching a new webinar series beginning with “Preparing for and Handling an FDA Inspection” on Thursday, May 14th at 2:00 pm EDT. Ever a responsive and supportive partner to its clients, these webinars are Lachman Consultants latest effort in providing timely and critical […]
From March 31 through April 14, 2020, Lachman Consultant Services, Inc. (Lachman Consultants) conducted a voluntary survey of professionals working in the pharmaceutical, biotechnology, medical device and other sectors related to the greater life sciences industry. The purpose of the survey was to take a “pulse” of the overall organizational and industry impact of the […]
Survey closes 5:00pm EDT on Tuesday, April 14th! Lachman Consultant Services, Inc. is surveying the impact of COVID-19 on the Global Life Sciences Industry. Please take a moment to complete this brief survey as we take a “pulse” on the impact of COVID-19 on your organization. LAUNCH THE SURVEY We sincerely appreciate your input […]
As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]
FDA has announced the 12th Annual FDA Sentinel Public Workshop on April 20-21, 2020. (Please go here for the details.) The Sentinel System is the largest multi site patient safety database in the world, and includes the Active Post-marketing Risk Identification and Analysis (ARIA) system mandated by Congress in the US Food and Drug Administration […]
I am saddened to report that on Saturday January 4, 2020 my (our) good friend Don Hare passed away peacefully after a brief illness. When I heard the news, my heart broke. For those of us in the FDA or in the drug industry, he stood as a man among men and will be sorely […]
Each year at holiday time, we try to provide a little levity in some of our blog posts, as well as spread some good cheer. So here you go – love it or not – we fully expect this to be sung outside Building 31 in Bethesda on the evening of December 24th. To the […]
