26
Jun

Mastering Drug Product Remediation: 5 Essential Principles Post FDA Action 

In the realm of pharmaceuticals, navigating the intricate landscape of facility and Quality Management System (QMS) remediation following FDA enforcement actions demands precision, foresight, and a commitment to sustainable change. When faced with regulatory scrutiny, it is imperative for companies to not only address the identified issues but also to comprehensively understand the root causes […]

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26
Jan

Lachman Consultants will be at Access! 2024 in February. Will you?

As a proud Silver Sponsor of this important conference, we’ll be looking for you at Access! 2024. This annual meeting of the Association for Accessible Medicines (AAM) is happening in Tampa, Florida at the JW Marriott from Monday, February 5th through Wednesday, February 7th, 2024. Visit with us at Booth #11. The Lachman Consultants team […]

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26
Oct

Join Lachman Consultants (Ireland) at the PDA Quality and Regulations Conference in Belgium

Lachman Consultants (Ireland) will participate at this year’s PDA Quality and Regulations Conference in Antwerp, Belgium, November 7 – 8. The two-day in-person event will cover a wide range of topics related to regulatory and industry best practices, with a particular emphasis on addressing shortages and enhancing supply chain resilience. Lachman Consultants (Ireland) will be […]

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11
Oct

Connect With the Lachman Consultants Team at the 2023 ISPE Annual Meeting

ISPE 2023 Annual Meeting Mandalay Bay Resort Las Vegas, NV October 16th – 18th, 2023 We are looking forward to seeing you at the 2023 ISPE Annual Meeting & Expo. This annual event will usher in a revitalized focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing. MEET WITH LACHMAN CONSULTANTS AT BOOTH […]

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05
Oct

GRx+Biosims Presentation Recap: FDA Expectations for Biosimilar Manufacturing Inspections

On day 2 of the AAM GRx+Biosims conference, a learning track regarding FDA Expectations for Biosimilar Manufacturing Inspections was presented by members from both the FDA and private industry.  Speakers included: Chris Downey, Ph.D., Division Director, CDER; Shawn Allwein, Ph.D., Vice President Biologics CMC, Teva; and Michael Cutter, Ph.D., Chief Quality Officer, Biocon.  Dr. Downey opened […]

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25
Sep

Lachman Consultants to Participate at This Year’s GRx+Biosims 2023 in October

Join Lachman Consultants at GRx+Biosims™ 2023 in North Bethesda, MD, Oct 2 – 4 for three days of insights and engaging discussions around the most pressing issues vital to the generics and biosimilars industry. Lachman will be represented by several members of the team, including: Frances Zipp, President & CEO Bob Pollock, M.S., Outside Director […]

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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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24
Aug
Mock-Inspection-Blog-image-Lachman-Consultants

5 Reasons Why You Should Perform a Mock Inspection Now

As U.S. consumers are facing critical drug shortages, leading Congress to question the FDA’s foreign inspection program, particularly for products with supply chains from India and China, the oversight of CGMP inspections is high on the Agency’s radar. With approximately 32% of generic drugs and 45% of active pharmaceutical ingredients (APIs) from these two countries, […]

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