Inspections

31
Oct

OGD Published GDUFA III Commitment Letter

Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]

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21
Jul
Digital or electronic thermometer with high temperature 98,6 Fahrenheit in doctors hand. Doctor or nurse in protective PPE suit, face mask, safety googles and rubber gloves demonstrates temperature caused by covid 19, coronavirus or Sars-Cov-2

Domestic Inspections Back to Normal – Mission Critical Still for Foreign In-person Reviews

With the news that domestic inspections are back on track the question comes with what is the backlog and how long will it take to slug through the outstanding inspections work?  Question number 2 is then what do we anticipate seeing from these new domestic inspections? With it being over a year+ (March 2020) since […]

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15
Apr

Remote Inspection Guidance Now A Reality But Will It Solve the Backlog of Inspections?

Yesterday, the FDA issued a long-awaited guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency (here).  The guidance notes that the Agency will determine whether remote inspections will occur and which tools are appropriate as alternatives to on-site inspections but indicates that it will not accept […]

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14
Dec

Lachman Consultants’ Webinar Presents Latest Virtual Solutions for Remote Audits and FDA Inspection Preparation

There’s still time to register for Lachman Consultants’ free webinar, “Looking Ahead: Virtual Auditing for FDA Inspection Preparedness: Right Now, Next Year and Beyond.”  The event, which takes place Tuesday, December 15, 2020, from 11:00 am to 11:45 am EST, is an in-depth look at how organizations regulated by the FDA can utilize new virtual […]

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08
Dec

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]

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11
Nov

Congress Finds Interest in Foreign Inspection Postponements Due to the Pandemic

In March 2020, the FDA postponed all inspections of domestic and foreign drug manufacturing facilities due to the COVID-19 pandemic.  However, drug products manufactured overseas are still entering the U.S. market, prompting some U.S. Senators to voice their concern.  On November 10th, two members of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent […]

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09
Nov

Scott Deckebach to Participate in Virtual Panel Discussion on the “New Normal” for Quality Practices During Pandemic

On November 11, 2020, Lachman’s Scott Deckebach MBA, Director, Compliance, Lachman Consultants will be participating in a panel discussion during the 2020 Bio/Pharma Virtual Congress, “‘New Normal’ for Quality Practices”. This discussion will review quality and regulatory challenges amid the pandemic, focusing on new technologies such as remote monitoring, risk-based quality management, Annex 1 changes […]

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04
Nov
Person wearing VR gear

Is FDA Finally Ready to Use Advanced Technology to Perform Inspections During the Pandemic?

According to the Pink Sheet, Brian Hasselbalch, in CDER’s Office of Pharmaceutical Quality, stated, at an IPAC-RS roundtable on November 2, 2020, that the FDA was developing guidance on virtual drug GMP audits and inspections using interactive video or other types of interactive tools and techniques. He noted that many companies have volunteered use of […]

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29
Sep

Virtual Inspections Bringing Needed Expertise Remotely

Since the start of the pandemic when travel was limited, Lachman Consultants has been performing virtual inspections.  In fact, we have performed audits and inspections at the same rate as we did before the pandemic, only now, most of them are remote. We have been at the forefront of implementing effective state-of-the-art solutions.  During this […]

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17
Jul

Mary Oates to Participate in Webinar on Virtual Inspections

On Tuesday, July 21, Mary Oates, Ph.D., Vice President, Compliance Services, will be participating in a webinar organized by Informa, publishers of the Pink Sheet and Scrip. Mary will be a panelist in a session on Virtual Drug Inspections, occurring at 2 PM EST. The entire webinar series, which is taking place over a 24 […]

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