Uncategorized

06
Jul

Ripple Effects of Expediting Vaccine Development

Recently I had the opportunity to make a presentation to the CPHI Learning Lab on the topic of The Ripple Effect of Expediting Vaccine Development and the profound social, economic, and operational effects the COVID-19 pandemic has had on our industry. On February 4, 2020, the Department of Health and Human Services (“HHS”) issued the […]

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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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03
Jun

Data Integrity Series: Episode 1

FDA warning letters have doubled since 2015 and more than 50% of observations involve data integrity. Fines up to $1 million per incident are possible. Get prepared and avoid the fines. “The primary purpose of this message is solely to educate and inform. Lachman Consultants Services, Inc. assumes no liability for the accuracy and completeness […]

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22
Apr

FDA Says its Recent QSR Amendment will Streamline the Path to Market for Medical Device Providers

GET EXPERT ADVICE AT MEDTECH FORUM 2022 After four years in the works, the U.S. Food and Drug Administration (FDA) has finally published their much-anticipated proposed rule (PR) to amend the Quality System Regulation (QSR) (21 CFR Part 820) on 2/23/2022. This proposed rule not only impacts U.S. manufacturers but all manufacturers with product in […]

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09
Feb

Frances Zipp to Moderate WiHP Healthcare Leadership Luncheon at AAM Annual Meeting

Join Frances Zipp, President and CEO of Lachman Consultant Services, Inc., at the AAM Annual Conference, Access! 2022, where she will moderate the WiHP Healthcare Leadership luncheon. The panel discussion will be held on February 15, 2022, at 12:30 pm. Frances will be joined by AMCP CEO Susan Cantrell, AHIP’s EVP of Government Affairs and […]

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09
Feb

Frances Zipp to Moderate WiHP Healthcare Leadership Luncheon at AAM Annual Meeting

Join Frances Zipp, President and CEO of Lachman Consultant Services, Inc., at the AAM Annual Conference, Access! 2022, where she will moderate the WiHP Healthcare Leadership luncheon. The panel discussion will be held on February 15, 2022, at 12:30 pm. Frances will be joined by AMCP CEO Susan Cantrell, AHIP’s EVP of Government Affairs and […]

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