27
Jan
Ireland USA Puzzle Concept

Friendshoring: Irish American Supply Chain Examined as a Case Study

How is your company reacting to threats in its supply chain and transforming risk into opportunity?  In a mature application of Quality Risk Management (QRM), companies should lean into the political winds of “onshoring,” “nearshoring,” and “friendshoring” as these concepts have been stood up as well-discussed risk mitigations to the current drug shortage problems.  These […]

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23
Jan

Synthetic Data: Real or Fake?

Whether you believe synthetic data to be real or fake, the overall market for it is expected to grow from $351.2 million in 2023 to $2,339.8 million by 2030 (Synthetic Data Generation Market Forecast | Fortune Business Insights).  This statistic can make the most hardened cynic’s ears perk up.  But, surely, in our world of regulated medicinal […]

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17
Jan
businessman shake hands, metaphor for logistics and business meetings Delivery logistics service for tiny businessman flat vector illustration. website design or landing web page

New Release: Global Drug Supply Chain Diversification Alert White Paper

Lachman Consultants has continued its active engagement with efforts to combat the global drug supply chain shortages.  Despite the FDA’s significant success in helping to prevent 236 drug shortages in 2023, the problem persists and may be about to get worse.  The current problem, external environment, and emerging risks are highlighted in a recent publication […]

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11
Sep
PDA Conference Day 2 - An Overview - Lachman Consultants

PDA Conference Day 2 – An Overview

Day 2 of the 2024 PDA/FDA Joint Regulatory Conference kicked off in a similar format to Day 1 with a panel discussion, moderated by Andrew Hopkins, that delivered key messages from various FDA leaders.  An explanation of the imminent changes in the Agency’s organizational structure (CBER, CDER, and CVM) dominated the conversation.  However, an impactful response from […]

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10
Sep
U.S. and EU Drug Shortages - Lachman Consultants

New Risks Discovered as U.S. and EU Drug Shortage Efforts Start to Merge

U.S. and EU efforts to manage supply chain shortages are slowly converging; however, the political winds in the Rest of World (ROW) may be diluting required oversight.  Both the U.S. (Risk Management Plans to Mitigate the Potential for Drug Shortages | FDA) and EU (Shortage Prevention Plan (SPP) – template (europa.eu)) have published either a […]

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28
Aug
Pharma What Can We Learn from the Infamous CrowdStrike Outage - Lachman Blog

Pharma, What Can We Learn from the Infamous CrowdStrike Outage?

A couple of months ago, when we returned from Barcelona to San Francisco, it was impossible to check in online for some reason. Then the news broke about flight disruptions due to the CrowdStrike software update! Some flights, including ours, were only a couple of hours delayed. However, many more passengers were affected even further […]

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10
Jul
Agency and Industry Discuss Drug Supply Chain Policy Solutions - Lachman Blog

Agency and Industry Discuss Drug Supply Chain Policy Solutions

Did you ever REALLY wonder what is being done by our federal government and other stakeholders to combat the current drug shortage situation? This past June 12th, representatives from various government agencies as well as industry leaders and the Duke-Margolis ReVAMP Drug Supply Chain Consortium (with yours truly participating on the expert panel) met to […]

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09
Jul
The Emerging QA Skills Gap - Lachman Blog

The Emerging QA Skills Gap

When new technology takes the industry by storm, does your QA team have the “education, training, and experience” necessary to execute their required responsibilities? Even when outsourced, the contract giver needs to have the requisite skills to provide adequate oversight. These concepts are also summarized in the FDA publication “Q10 Pharmaceutical Quality System” regarding both […]

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20
May
AI developments blog 20May2024 - Lachman Consultants

Are AI Developments Outpacing Your QMS Maturity?

Forget the cadence of the traditional three-to-five-year business plan when it comes to Artificial Intelligence (AI). The pace of change in this environment has indicators that need to be followed on a quarter-by-quarter basis. In Q1, we wrote about the fast evolving environment both from the legal perspective and the regulatory aspect in blogs that […]

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