On April 25, Terri Nataline and Fran Zipp participated in a summit focusing on global strategies for Indian pharmaceutical companies, the Annual Global Pharma Regulatory Summit, in Mumbai, India. This summit brings together global regulators who shared their knowledge about complying with international regulatory guidelines for manufacturing and exporting pharmaceuticals. Terri Nataline, Principal Consultant, presented in 2 sessions dealing with US FDA specific requirements,
On April 21, President and CEO of Lachman Consultants Fran Zipp gave a presentation at the 6th Annual Generic International Summit (GIS) in Shanghai, China. Her talk, “Data Integrity and Quality Culture” was part of a session on “Consistency Evaluation and Formulation”. She discussed the history of Application Integrity Policy (AIP), recent trends in data integrity related enforcement actions in the US and ex-US,
Lachman Consultants was the Business Exposition Sponsor at the Generic Pharmaceutical Association Annual Meeting in Orlando, held February 22-24, 2016. If we didn’t see you there, we hope to see you at our booth there next year!
From March 14-15, LCS hosted a booth at the PDA Annual Meeting in San Antonio, Texas. The meeting was attended by over 850 pharmaceutical professionals, representing both industry and regulators. Linda Evans O’Connor, Director, and Michele Sinoway, Senior Manager, met with many potential clients and FDA representatives, and are sure this will be a very productive meeting for LCS.
On Tuesday, March 15, 2016, our President and CEO Fran Zipp and Senior Associate Terri Nataline presented in a forum entitled “GDUFA II and GMP API Inspection Trends: The Business Impact of Upcoming Regulatory Changes” at DCAT Week. DCAT Week is the premier business development event for companies engaged in pharmaceutical development and manufacturing and related industries.
When most people hear of Amazon.com, they think of one of the largest online marketplaces for consumer products. What people may not realize is that Amazon is also one of the largest providers for computer power for cloud computing through their subsidiary Amazon Web Services (AWS). Running applications in the cloud is a relatively new concept for many industries,
I am pleased to announce that effective January 1, 2016, Frances “Fran” Zipp is President & Chief Executive Officer of Lachman Consultants.
The International Society for Pharmaceutical Engineering has launched a drug shortage assessment and prevention tool that helps drugmakers identify risks early on.
Fran Zipp, President of Lachman Consultants, presented at the 2015 ISPE Annual Meeting, November 8-11 at the Philadelphia Marriott Downtown. She spoke about the launch of the ISPE Drug Shortage Assessment and Prevention Tool, on Monday, November 9 at 10:45 AM. For a preview of the tool, please see this article authored by Fran in November’s issue of Pharmaceutical Engineering.
Lachman Consultants recently exhibited at BioProcess International Conference and Exposition at the Hynes Convention Center, Boston, MA.
Serving as a member of the pharmaceutical industry is a privilege that brings with it significant personal responsibility. In recent years, preventing and mitigating drug shortages has become a critical concern for every pharmaceutical professional. ISPE is leading an international effort to understand, assess, and educate patients, providers, regulators, and manufacturers on this critical topic.
Many of you reading this blog may not remember the Star Trek “Replicator”. In the Trek far future, members of the crew, when hungry, would simply walk up to this device and key in what they wanted to eat. The Replicator would then build a suitable, tasty meal by mixing the right combinations of materials.
Well, as someone who routinely reviews regulations.gov postings from the FDA, this comes as a bit of a surprise, because on some docket items there are literally thousands of comments to sift through. Turns out that a pre-publication Federal Register notice (here) released today indicated that, back in 2007 when FDA merged its postings to regulations.gov,
Frances (Fran) M. Zipp has been selected by the Board of Directors of Lachman Consultant Services to be President effective March 3, 2014
Lachman Consultant Services, Inc. is proud to announce that Dr. Leon Lachman received a lifetime achievement award from Long Island University’s College of Pharmacy.