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 […]
Join Lachman Consultants at the 27TH Annual Medicines for Europe Conference Fran Zipp Will Present as Part of Keynote June 29th to July 1st, 2022 Dolce Sitges Hotel, Sitges (Barcelona) Fran Zipp Will Present as Part of Keynote We hope to see you at this exceptional industry conference where Frances Zipp, President and CEO of […]
On Thursday, June 30th, at the Annual Conference of Medicines for Europe, Frances Zipp, President and CEO of Lachman Consultant Services, Inc., will be addressing the audience as a part of the Keynote Speech at the Dolce Sitges Hotel in Barcelona, Spain. Fran will be addressing humanitarian efforts by industry to provide patients in war-torn […]
The US Food and Drug Administration published their much-anticipated proposed rule (PR) to amend the Quality System Regulation (QSR) (21 CFR Part 820) on February 23, 2022. After four years in the works and much debate about what the PR would include, we can finally read it for ourselves. The question in my mind was […]
Last week, Lachman hosted a virtual booth at the GRx+Biosims 2021 interactive event, where we engaged in a series of dynamic discussions around issues, trends, and challenges vital to the generic and biosimilar medicines industry. The three-day event also featured a podcast special with AAM CEO Dan Leonard and Lachman Senior Advisor Bob Pollock. The […]
Last week, Lachman hosted a virtual booth at the GRx+Biosims 2021 interactive event, where we engaged in a series of dynamic discussions around issues, trends, and challenges vital to the generic and biosimilar medicines industry. The three-day event also featured a podcast special with AAM CEO Dan Leonard and Lachman Senior Advisor Bob Pollock. The […]
Data integrity is an ever-increasing concern in life sciences evidenced by the recent activities of the FDA placing its watchful eye on the evolving medical device industry, for the purpose of ensuring safety, and enhancing quality among all manufacturers. Coming under recent scrutiny in the area is data integrity and its far-reaching impact on manufacturing […]
Then this video is for you. In just five minutes, you’ll discover how the passion for what we do translates into the successful delivery of specialized expertise and services that help you overcome the challenges of an ever-evolving compliance and regulatory environment. The video outlines how you’ll find passion in everything we do, and how […]
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 […]
