Ricki Chase, Executive Director, Compliance, will be presenting a webinar “FDA Regulations and Inspections Amid COVID-19” as part of the Contract Pharma 2020 Contracting and Outsourcing Conference. Her presentation will be on September 30, 2020, 1 PM EST. Please register at this link. The entire agenda and registration for other talks in the series, which […]
Earlier this month, Ricki Chase, Executive Director, participated as a presenter in the webinar “Drug Supply Chain Security Act: Legal Overview and Cross-Enterprise Compliance Strategies” in collaboration with Howard Sklamberg (Partner) and Abraham Gitterman (Senior Associate) of Arnold & Porter. In this webinar, the following was covered: The basics of the Drug Supply Chain Security […]
In 2019, FDA issued the first Warning Letter for violations of the Drug Supply Chain Security Act, signaling its heightened attention to supply chain and distribution issues. Since DSCSA was enacted in 2013, various provision have come into effect. It is important for companies not just to understand the law’s requirements, but also how to […]
We are pleased to announce that Rebecca Welton has accepted the position of Senior Associate in the Regulatory Practice at Lachman Consultants, effective August 3, 2020. Ms. Welton is an experienced Science, Operations and Regulatory leader with 25+ years in the pharmaceutical industry, holding positions of escalating accountabilities in chemistry, formulation, management, pilot plant, and […]
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 […]
Globally, the COVID-19 pandemic has required changes in the way regulators worldwide have been approaching the inspection of manufacturing facilities. Please join us for a webinar presented by PDA sponsored by Lachman Consultants titled “Remote and Virtual Inspections during the COVID-19 Pandemic: Regulator Perspectives” on June 29 from 10 am-11:30 AM EST to gain some […]
Globally, the COVID-19 pandemic has required changes in the way regulators worldwide have been approaching the inspection of manufacturing facilities. Please join us for a webinar presented by PDA sponsored by Lachman Consultants titled “Remote and Virtual Inspections during the COVID-19 Pandemic: Regulator Perspectives” on June 29 from 10 am-11:30 AM EST to gain some […]
Lachman Consultants recently participated in a webinar with Arnold & Porter called “FDA Inspection Alternatives During the COVID-19 Pandemic: Requesting, Preparing for and Responding to FDA Virtual Inspections”. If you missed it, don’t despair – there is a recording of it, which can be found here. We hope you enjoy it, and look forward to “seeing” you at […]
Globally, the COVID-19 pandemic has required changes in the way regulators worldwide have been approaching the inspection of manufacturing facilities. Please join us for a webinar presented by PDA sponsored by Lachman Consultants titled “Remote and Virtual Inspections during the COVID-19 Pandemic: Regulator Perspectives” on June 29 from 10 am-11:30 AM EST to gain some […]
Due to COVID-19 travel and safety concerns, the Food and Drug Administration has suspended most of its foreign and domestic inspections. In order to avoid delays in evaluating applications to market drugs, devices and biologics because of the lack of an in-person inspection, FDA has recognized the need to rely on alternatives, such as virtual […]
