07
Oct

Managing Risks of an Outsourced Facilities Management Program Webinar

Join Lachman Consultants’ Data Integrity Consultant Patrick Day for a live webinar, Outsourced Facilities Management. The 90-minute session will be held on November 9th at 10:00 am EST and November 16th at 1:30 pm EST. A manufacturing operation is only as good as the facility that supports it. As more businesses outsource their facilities management […]

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04
Oct

Connect with Lachman Consultants at the 2022 ISPE Annual Meeting

ISPE 2022 Annual Meeting Gaylord Palms Resort & Convention Center Orlando, FL October 30th – November 2nd, 2022 We are looking forward to seeing you at the 2022 ISPE Annual Meeting & Expo. This annual event will usher in a revitalized focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing. FEATURED SPEAKER Day […]

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01
Sep

Lachman and Law Firm Arnold & Porter to Host Webinar on FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics

Join Lachman Vice President John McShane and Executive Director Keith Lamb with Arnold & Palmer attorneys Howard Sklamberg and Phillip DeFedele for a live webinar, FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics. The 1 hour session will be held on September 15 at 1:00 pm EST. Cell and […]

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04
Aug

Responding to Consumer Complaints While Working with CMOs

Ricki Chase, M.S., Vice President, Lachman Consultant Services, Inc. (Lachman Consultants) and Carrie Colella, Senior Director, Lachman Consultant Services, Inc. (Lachman Consultants) take an in-depth look at the questions and challenges manufacturers face and how to respond to consumer product complaints while working with a contract manufacturing organization (CMO). The product, in this case, may […]

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11
Jul

Lachman Consultant Services, Inc. Names Marty Shimer as Executive Director, Regulatory

(Westbury, NY – July 11, 2022) – Frances Zipp, President and CEO of Lachman Consultant Services, Inc. (Lachman Consultants), a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, announced today that CAPT Martin H. Shimer, II joined the firm as Executive Director, Regulatory, effective July 11, 2022. In this […]

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27
Jun

CONTRACT PHARMA ARTICLE: ICH – Q14 Regulatory Report

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 […]

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14
Jun

Fran Zipp to Present at Medicines for Europe

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 […]

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24
Feb

QSR – ISO Harmonization – All Things Being Equal…They Are Not – A Deeper Dive

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 […]

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