Women in Pharma Debuts at 2016 ISPE Annual Meeting & Expo

ISPE presented the first in a series of planned annual events entitled, “The Women in Pharma” on Monday 19 September at its 2016 Annual Meeting. Key female pharmaceutical industry executives shared their stories at the morning session, focusing on the challenges and opportunities each embraced as they progressed though their careers.

The session was led by Charlotte Enghave Fruergaard,

The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing

An article authored by Jim Davidson, Ph.D, Vice President, recently appeared in the July-August issue of Pharmaceutical Engineering. This very timely article, “The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing”, has also been the subject of White Papers authored by LCS, as well as the topic of numerous industry symposia. Congrats to Jim on a job well done!

Ricki A. Chase, New Director, Compliance Practice at Lachman Consultant Services, Inc.

We are pleased to announce that Ricki A. Chase will join Lachman Consultants as a Director in the Compliance Practice, effective June 20, 2016.

Ricki Chase comes to Lachman Consultants after an impressive 16-year career, culminating as Director, Investigations Branch at the U.S. Food and Drug Administration where she was responsible for all operations of the Investigations Branch,

LCS to Exhibit at the ISPE/FDA/PQRI Quality Manufacturing Conference

On June 6-8 at the Bethesda North Marriott Hotel, ISPE will be hosting the 4th annual Quality Manufacturing Conference, in collaboration with FDA and PQRI. Lachman Consultants is the sponsor of the Welcome Reception as well as the conference badges. In addition, we will be exhibiting in the hall at table 3. Please stop by our booth for a chance to win an iPad,

White Paper: Navigating Through the Clouds in Life

Whether we embrace it or not, the Data and Application economy is upon us. Every business is, in some respects, a digital business, and in the digital realm things change FAST.

The term ‘cloud’ as a technology concept has been in use since at least 1971, but even as recently as 2009 companies like IBM were just introducing it to prospective clients.

White Paper: The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing

Every business faces risk. Broadly speaking, the primary categories of business risk are Market, Financial, Execution, and Regulatory. Successful companies have developed a core competency in managing for these risks, turning risk management into a sustainable competitive advantage. For drug manufacturers, recent trends have underscored the importance of managing Regulatory risk in order to remain a viable business. 

Terri Nataline and Fran Zipp Present at the 5th Annual Global Pharma Regulatory Summit

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,

Fran Zipp Presents at the Generic International Summit

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,

LCS Exhibits at PDA Annual Meeting

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.

Fran Zipp and Terri Nataline Present at DCAT Week

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.

Cloud Computing? Keep Your Head Out of the Clouds by Making Sure your Data is GxP Compliant

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,