Anyone who has been involved in basic science knows that the ultimate goal is publication of your research in a peer reviewed journal. If you work in discovery in a firm, the goal is the same, and the company looks to commercialize promising leads as potential therapeutics. We are happy to announce that one of […]
Join Lachman Consultants’ Data Integrity Consultant Patrick Day for a live webinar, Outsourced Facilities Management. The 90-minute session will be held on November 9th at 10:00 am EST and November 16th at 1:30 pm EST. A manufacturing operation is only as good as the facility that supports it. As more businesses outsource their facilities management […]
ISPE 2022 Annual Meeting Gaylord Palms Resort & Convention Center Orlando, FL October 30th – November 2nd, 2022 We are looking forward to seeing you at the 2022 ISPE Annual Meeting & Expo. This annual event will usher in a revitalized focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing. FEATURED SPEAKER Day […]
Join Lachman Vice President John McShane and Executive Director Keith Lamb with Arnold & Palmer attorneys Howard Sklamberg and Phillip DeFedele for a live webinar, FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics. The 1 hour session will be held on September 15 at 1:00 pm EST. Cell and […]
Ricki Chase, M.S., Vice President, Lachman Consultant Services, Inc. (Lachman Consultants) and Carrie Colella, Senior Director, Lachman Consultant Services, Inc. (Lachman Consultants) take an in-depth look at the questions and challenges manufacturers face and how to respond to consumer product complaints while working with a contract manufacturing organization (CMO). The product, in this case, may […]
(Westbury, NY – July 11, 2022) – Frances Zipp, President and CEO of Lachman Consultant Services, Inc. (Lachman Consultants), a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, announced today that CAPT Martin H. Shimer, II joined the firm as Executive Director, Regulatory, effective July 11, 2022. In this […]
In our previous installment on inspectional preparation and conduct, we covered recommended actions to be inspection ready, how to interact with FDA, and how personnel should conduct themselves during an FDA inspection. In today’s installment, we will cover what happens after the inspection, focusing on responding to an FDA 483 and inspectional outcome decision making. […]
In our previous installment, Tamil Arasu, former investigator with FDA, detailed preparations that a firm can make in advance of an FDA inspection, as well as details on the types of inspections that FDA performs on drug firms. In today’s post, Tamil will describe appropriate conduct during an inspection, including both the personnel that will […]
When an FDA investigator walks into your facility and informs you that they are going to conduct an inspection, a tense moment may arise even at the most cGMP (Current Good Manufacturing Practices) compliant facility. Paging the employees to inform them of the presence of FDA at the facility is a common occurrence so that […]
CONTRACT PHARMA ARTICLE: ICH – Q14 Regulatory Report: Analytical Procedure Development Paul Mason, Ph.D., Senior Director at Lachman Consultant Services, Inc., offers analysis and commentary on the draft of the new ICH Quality Guideline, ICH Q14, Analytical Procedure Development, and revision of ICH Q2(R2), Guideline on Validation of Analytical Procedures. In this informative article, Paul […]
