Inspections News and Articles Archives

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

By Bob Pollock Nov 09, 2020 Compliance FDA Inspections News Quality Virtual Inspections

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 […]

Nov

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

By Linda Evans O'Connor Nov 04, 2020 Compliance FDA Inspections

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 […]

Sep

Virtual Inspections Bringing Needed Expertise Remotely

By Linda Evans O'Connor Sep 29, 2020 Compliance FDA Inspections

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 […]

Jul

Mary Oates to Participate in Webinar on Virtual Inspections

By Webmaster Lachman Jul 17, 2020 CBER CDER CDRH cGMPs Compliance FDA IND Inspections News Virtual Inspections Webinar

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 […]

Apr

Impact of COVID-19 on European Inspections

By Linda Evans O'Connor Apr 24, 2020 Compliance EU Inspections Regulatory Affairs

The European Commission, the European Medicines Agency (EMA), and national competent authorities have recently issued an updated Question and Answers document on Regulatory Expectations for Medicinal Products for Human use during the COVID-19 Pandemic. The guidance can be found here. The guidance covers the following topics: Issues related to marketing authorizations, marketing authorizations procedures Manufacturing, […]