Manufacturing

12
Sep

Lachman to Participate at the PDA/FDA Joint Regulatory Conference

Join Lachman Consultants in Washington, DC, Sep 18-20, for the 2023 PDA/FDA Joint Regulatory Conference. Themed “CGMP: Quality Through Science and Innovation,” this year’s event will delve into the pivotal role effective quality systems play in ensuring an ongoing state of control throughout the product lifecycle. As a Silver Sponsor at this year’s event, Lachman […]

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04
Aug

New Guidance for Industry- Acceptable Intake Limits for NDSRIs and a New Webpage from FDA

Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both FDA and industry are having with Nitrosamines impurities in pharmaceutical products.  As a reminder, APIs are at risk of forming nitrosamine drug substance-related impurities (NDSRIs) when they contain secondary amines or dimethyl tertiary amines. We have published many blogs […]

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03
Aug

Connect with Lachman Consultants at ISPE Singapore Affiliate Conference & Exhibition August 23 – 25, 2023

Join Lachman Consultant Services, Inc. online and in-person at Suntec Singapore for the 2023 ISPE Singapore Affiliate Conference & Exhibition, August 23rd – 25th. The exhibition showcases the latest technologies and services for pharmaceutical and biomanufacturing. The three-day conference is expected to include more than ninety international exhibitors and sponsors. Lachman Consultants is pleased to […]

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11
Jul

Removing Quality Roadblocks For Cell & Gene Therapies

REMOVING QUALITY ROADBLOCKS FOR CELL & GENE THERAPIES REGISTER HERE Keith Lamb, Executive Director, Lachman Consultant Services, Inc., will be joined by a panel of Cell & Gene Therapy (CGT) industry experts from leading organizations as they discuss the key considerations of successful CGT manufacturing and quality strategies. Roundtable topics will include: • Developing a […]

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26
Oct

Data Integrity Series: Episode 6

Data integrity is not only fundamental to a company’s license to operate and to drive new stakeholder value. It’s simply smart business. Does your company have a sustainable, cost-effective global data governance program? Get the answers you need. Watch the following video and talk to Lachman Consultants. The primary purpose of this message is solely […]

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18
Oct

Data Integrity Series: Episode 5

A strong organizational culture is essential for maintaining the quality and integrity of your company’s data. Does your company have a data-integrity-centric culture? Get the answers you need. Watch the following video and talk to Lachman Consultants. The primary purpose of this message is solely to educate and inform. Lachman Consultants Services, Inc. assumes no […]

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26
Sep

Data Integrity Series: Episode 4

Episode #4 of our six-part Data Integrity video series focuses on Systems and Processes, two more essential elements for minimizing and eliminating data integrity issues. The video explains the four key points of Systems and Processes necessary for establishing a world-class data integrity program and the two primary controls that well-established Systems and Processes provide. […]

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08
Sep

Data Integrity Series: Episode 3

Our latest video in the Lachman Consultants Data Integrity Series, “People and Organization – The First Essential Elements of a World-Class Data Integrity Program” reveals how good people and organization practices can have a most pronounced impact on reducing your overall data integrity risk. How well is your company incorporating people and organization into its […]

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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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10
Aug

Data Integrity Series: Episode 2

Traditionally, data integrity programs have focused on electronic systems, but to keep pace with the industry, your company must evolve. Achieving digital maturity requires companies to develop a multi-dimensional program of governance for their data. Learn what a well-conceived program that achieves lasting data integrity consists of. “The primary purpose of this message is solely […]

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