Lachman Consultant Services

In AmCham’s 2024 US-Ireland Business Report: ‘Building Ireland’s Transatlantic Impact’, John Darby M.Sc. Executive Director, Lachman Consultants and Pat Day M.S. Principal Consultant, Lachman Consultants (Ireland) Limited spoke about the importance of global digitalisation and the impact that it is having MedTech and Pharmaceutical Industries. They said: “A company’s competitive edge may very well hang on its ability to integrate the technology, processes, and people into an optimised program for unique and actionable insight. This can be best placed into a strategic plan to integrate ongoing data governance maturity into the holistic digital strategy. Just focusing on the technology itself can exacerbate an already known gap with a key function within Pharma and Device companies. Across the pharmaceutical sector globally, digitalisation is happening and companies not investing in this area will quickly be behind the curve in adoption. Credible areas of successful digitalisation are being implemented in pharma and devices in targeted areas of need such as: Supply Chain monitoring and resilience; Supplier-Manufacturer digital transfer of information; Supply Chain anti-counterfeit programs. In parallel, regulators are investing in their own systems and capabilities for similar areas such as the EMA strategy to utilise AI to combat supply chain challenges (1) and the FDA’s draft guidance on assessing risks in the supply chain. (2)" You can read the full article by John and Patrick and view the advert by Lachman Consultants online here: https://lnkd.in/eNabimH5 #USIRL24

READ: FDA Makes Another Significant Move with Biosimilar Guidance – Albeit Somewhat Subtly!  https://lnkd.in/eFwDwp9R #FDA #CDER #biosimilars #biosims #biologics

Delivering your Digital Strategy: Key Success Factors https://lnkd.in/gGPBWv8v Authors: Martha Ni Chuanaigh & Charles Gibbons "In an era when adoption of digital technologies is key to future competitiveness and company success, the following are important factors to consider for..." Tap to Read More! #Compliance #DataIntegrity #DigitalTools #DigitalStrategy #EMA #FDA

Want to learn about the "Keys to a Successful Cell & Gene Therapy Quality System"? Then don't miss the session presented by John McShane at the Orange County Regulatory Affairs Discussion Group Annual Conference on Friday, August 2nd! This presentation will cover: 1. Specific Cell & Gene Therapy (#CGT) Quality System Requirements 2. Implementation Guidance Interested in meeting us at the conference? Get in touch today: https://lnkd.in/eMRWw8Px More info about the conference: https://lnkd.in/gMEYefwY #OCRAdg30 #OCRAannualconference #cellandgenetherapy #QMS #Sponsor

LATEST: #QMM Don't miss our blog "QMM Still a Hot Topic" by Marian Meyer. https://lnkd.in/eqRT3Fp6 "The FDA Quality Management Maturity (QMM) program has generated an increased interest in quality culture in the pharmaceutical industry. The Center for Drug Evaluation and Research (CDER) has established a program to encourage manufacturers of drugs (including biologics), with the stated purpose of..." Tap the link to Read More! #QualityCulture #Quality #FDA #Compliance #QualityMaturity

BLOG: Revised Q&A Guidance Gives Firms More Tools to Deal with Misinformation – Or Does It? https://lnkd.in/ecmXwfBY Author: Bob Pollock #Advertising #Compliance #Labeling #RegulatoryAffairs

READ: Agency and Industry Discuss Drug Supply Chain Policy Solutions https://lnkd.in/erqqksK3 Author: Pat Day "This past June 12th, representatives from various government agencies as well as industry leaders and the Duke-Margolis ReVAMP Drug Supply Chain Consortium met to discuss policy solutions to improve the reliability of U.S. drug supply chains." Click to Read More! #SupplyChain #DrugShortage #Quality Duke-Margolis Institute for Health Policy

READ: May Official Approvals and Other Stats, Along with Full FY Projections https://lnkd.in/eWfsZhm6 "May was a good month for the OGD in terms of approval actions and a few other statistical parameters. The OGD issued 71 final-approval actions and 13 tentative-approval actions in May 2024." Tap on the article link to learn more! #FDA #OGD #Generics #RegulatoryAffairs

BLOG: The Emerging QA Skills Gap https://lnkd.in/eVAUHRes #AI #ArtificialIntelligence #Compliance "When new technology takes the industry by storm, does your QA team have the “education, training, and experience” necessary to execute their required responsibilities?" Author: Pat Day

See our latest article in Contract Pharma: "The Importance of Change Control within the Laboratory Setting" Exploring best practices for the employment of quality risk management within laboratory operations. https://lnkd.in/euE7vbmR Written by Paul Mason, this article covers specifics of change management in pharmaceutical quality systems, with particular attention to the laboratory setting. "Change management is essential to a pharmaceutical quality system, and it is considered one of the primary elements, as stated within ICH Q10.1 It is expected and understood that change is inherent to a cGMP setting, and, as such, there needs to be a systematic and structured process for addressing change..." Tap the Link to Read More! #quality #riskmanagement #qms #changemanagement #ICH #ICHQ10 #ContractPharma