“Leaders win through logistics. Vision, sure. Strategy, yes. But when you go to war, you need to have both toilet paper and bullets at the right place at the right time. In other words, you must win through superior logistics.” (Tom Peters – Rule #3: Leadership Is Confusing As Hell, Fast Company, March 2001), from […]
In today’s SBIA Generic Drug Forum, there were a number of presentations related to generic drug statistical reporting. As someone who tracks OGD activities somewhat obsessively, these presentations validated many of the observations that I’ve been making in my blog posts on the OGD’s public statistical reporting. The presenters reviewed the types of required and […]
Medical Device Week, a Lachman Learning Experience™ provided a great opportunity for industry professionals to gain knowledge and insight into a range of topics critical to the medical device industry. Our initial feedback indicates that those who participated found it valuable and highly informative. One of the most important topics covered was the FDA’s focus […]
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 […]
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 […]
Although though we are in the grips of a pandemic and our attention is focused on the development of treatments and vaccines for COVID-19, manufacturing of drug products to treat other conditions is continuing, and GMPs must still be maintained. Sponsor companies continue to manufacture products and are still dependent upon products and services from […]
Numerous health authorities have cited companies for inadequate sampling plans of finished drug products. A recent 483 issued to a finished drug‑product firm specifically mentions the firm’s lack of a scientifically sound statistical sampling plan during production of all strengths of its drug product. The FDA also mentions that this firm uses content uniformity results […]
