Risk Management

12
Sep

Lachman Consultants’ Webinar: Are You Considering Annex 1 Sterile Manufacturing Requirements?

Join us September 28th, 2023, at 10:00 AM EDT for A Lachman Learning Experience. Where are you on your Annex 1 journey? Have you created a measurable plan for progress? Assess your current position and start making plans for the future by attending this highly informative and valuable webinar. Join Lachman Consultants’ Executive Director Keith […]

Read More
12
Sep

Lachman to Participate at the PDA/FDA Joint Regulatory Conference

Join Lachman Consultants in Washington, DC, Sep 18-20, for the 2023 PDA/FDA Joint Regulatory Conference. Themed “CGMP: Quality Through Science and Innovation,” this year’s event will delve into the pivotal role effective quality systems play in ensuring an ongoing state of control throughout the product lifecycle. As a Silver Sponsor at this year’s event, Lachman […]

Read More
04
Aug

New Guidance for Industry- Acceptable Intake Limits for NDSRIs and a New Webpage from FDA

Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both FDA and industry are having with Nitrosamines impurities in pharmaceutical products.  As a reminder, APIs are at risk of forming nitrosamine drug substance-related impurities (NDSRIs) when they contain secondary amines or dimethyl tertiary amines. We have published many blogs […]

Read More
09
Jun

Supply Chain Risk and Data Management Poised to Take a Leap Forward

In a complete supply chain, one site’s lag measure is another site’s lead measure.  As important as data integrity is to product quality decisions at the site, data risks in the supply chain can affect availability of product to patients.  As mentioned in a previous Lachman blog (here), drug shortages are the preeminent risk for […]

Read More