Lachman Consultants (Ireland) and NIBRT have partnered to offer a short course to help directly address Aseptic Manufacturing Compliance, including Annex 1 requirements, developing implementation strategies, maturity assessment, and planning for sustainable improvements. Course Date: 4th October 2023 Location: On-site at NIBRT – Dublin, Ireland Learn more about the course, including who should attend, learning […]
Over the years Lachman Consultant Services, Inc. has participated in and donated to volunteer-based and charitable organizations as part of our corporate social responsibility (CSR) program. Our overarching value is in our ability to assist our clients as they help their patients, but equally as important is using our skillsets and our reach to help […]
Join Lachman Consultant Services, Inc. at PARKROYAL on Beach Road, Singapore for the 2023 PDA Pharmaceutical Manufacturing and Quality Conference, August 15th – 16th. The conference theme is “The Way Forward: Trends, Technologies and New Regulations Transforming Pharmaceutical Manufacturing.” Lachman Consultants is pleased to have Scott Deckebach, Senior Director of Data Integrity and Compliance, as […]
Lachman Consultant Services, Inc. is proud to be a Gold Sponsor of the 2023 PDA Robotics and Automation Conference. Taking place on Wednesday, May 3rd and Thursday, May 4th, 2023, in Amsterdam, The Netherlands, the two-day gathering builds a roadmap to digitization designed for drug manufacturing. This annual conference is designed to catalyze the transition […]
As with any regulatory submission, there are inherent risks associated with the submission and approval process if required data are incomplete or missing. In addition, compliance activities can play a major role in risks following approval and with commercialization of products. Some of the risks specific to 510(k)‑cleared devices include: Submission Rejection/Approvals: FDA 510(k) submissions […]
FDA 510(k) is a submission process that medical device manufacturers need to go through to receive clearance from the US Food and Drug Administration (FDA) in order to legally market their products in the US. The FDA 510(k) process is essential for ensuring public safety by confirming that medical devices meet the necessary standards and […]
Visit with Lachman Consultants at Booth #600. The PDA Annual Meeting is a must-attend event for professionals in the pharmaceutical and biopharmaceutical industries. The three-day 2023 event is being held on Monday, April 3rd to Wednesday, April 5th at the Hyatt Regency New Orleans. As a leading forum for knowledge-sharing and networking, this year’s event […]
Lachman Consultants’ Vice President Ricki Chase joined Arnold & Porter to discuss the introduction of the Modernization of Cosmetics Regulation Act (MoCRA) including FDA’s authority to formalize good manufacturing practice (cGMP) requirements for the cosmetics industry. This is a landmark change to how cosmetics are filed, manufactured, traced, and reviewed by the Food and Drug […]
