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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
