John Darby, M.Sc., Senior Director of Lachman Consultants, wrote a recent article for Contract Pharma applying the principles of Quality Risk Management to get medicines to market faster. Here is a brief excerpt from the article: “As vaccine development progresses globally to address the coronavirus pandemic, assurance of manufacturing capability to address supply needs is […]
After 30 years of being a major global pharmaceutical event uniting buyers and suppliers of fine pharmaceutical chemicals, CPhI in 2020 is moving to a virtual event. This year, CPhI festival of pharma will be held October 5-16, 2020. Fran Zipp, CEO and President, Lachman Consultants, will be participating in the Women in Leadership Forum, being held on Tuesday […]
When you can’t wait for answers to your GMP questions, it’s time for Lachman OnCall™. Our Subject Matter Experts (SMEs) understand you need advice right away. Lachman’s SMEs have the knowledge, experience, and skills to address your most urgent scientific, technology, and compliance-related questions, such as: “We had to shut down our sterile manufacturing plant […]
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 […]
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 […]
One unexpected outcome of the current global pandemic is that the world has received a crash course in basic microbiology. Ask just about anyone, anywhere in the world today, and they can tell you that diseases such as Covid 19 are caused by an organism too small to see, that can be passed person to […]
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 […]
