Quality issues

27
Mar

Will you be joining us at the American Biomanufacturing Summit?

You’re invited to visit with Lachman at Booth #47. We hope to see you at the 10th Anniversary American Biomanufacturing Summit, one of the can’t-miss events of the year. It’s taking place on April 10-11, 2024, at the Hyatt Regency San Francisco Airport, San Francisco, CA. The American Biomanufacturing Summit is one of the most senior-level […]

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13
Mar

We Hope to See You at the 2024 PDA Week

Visit with Lachman Consultants at Booth 635 PDA Week is a must-attend event for professionals in the biopharmaceutical and pharmaceutical industries. This year’s event is taking place from Monday, March 25th to Wednesday, March 27th in Long Beach, CA. As a leading forum for knowledge-sharing and networking, this year’s event promises to deliver insights into […]

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21
Feb

Join Lachman Consultants (Ireland) at the PDA Ireland Event: Contract Manufacturing – Achieving & Maintaining a Successful Partnership, Cork, 29th Feb.

The one-day event will explore how to achieve and maintain good relationships with your Contract Manufacturer Organisation (CMO) Partners. Key industry leaders will share their perspectives on many topics such as the selection of a service provider, regulatory trends, and how to foster collaborative synergies when outsourcing. Lachman Consultants (Ireland) provides a full range of […]

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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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01
Sep

Is your company suitably staffed? Our article in Contract Pharma takes this issue head on.

According to reports, the pharmaceutical job market has been expanding exponentially in recent months and is on an upward trajectory for job seekers. Occupational profiles are changing and many existing jobs, as a result of automation, are evolving, while completely new jobs are emerging. In this post-pandemic growth period, pharmaceutical companies are beginning to recognize […]

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20
Sep
Cropped shot of a team of colleagues showing thumbs up at work

Q&A Guidance for Frequent Quality Issues Posts on FDA Page

On Monday, September 20, 2021, a guidance document entitled Questions and Answers on Quality Related Controlled Correspondence (here) hit the FDA webpage late in the afternoon.  This document provides specific recommendations for generic drug quality issues that have been the raised repeatedly through controlled correspondence (CCs) submitted by numerous stakeholders.  OGD decided to issue the […]

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