Applying quality risk management to develop an isolator filling line

Following the patent of the innovative “Espresso” intravenous delivery device, the Italian Biochemical Institute (IBI) “Lorenzini” commissioned Comecer to construct a filling line to meet the unique requirements of the solution. Particle Measuring Systems’ advisory team leveraged their industry and regulatory expertise to oversee the development of the aseptic filling process and the environmental monitoring system by applying proven risk management techniques. Using this case study, we provide practical insights for Quality by Design principles with input from IBI and Comecer.
Watch Now

Spotlight

OTHER ON-DEMAND WEBINARS

The top 5 cybersecurity threats to pharma for 2022

It's no secret that pharma companies are struggling to protect themselves from cyberattacks amid the pandemic. Data breaches are costing the sector around US$5m a year, while one in 10 pharma companies are at risk of a ransomware attack, exacerbated by a perfect storm of shifting to remote working, increased growth, antiquated OT systems and a lack of cybersecurity skills.
Watch Now

The digital lab of the 21st century

Life science companies face major obstacles to continue operations and profitability. Examples include patent expirations, low research and development productivity, increased competition, decreased margins, non-optimized processes and mounting compliance pressure.
Watch Now

The Heart of Addiction: A Revolutionary New Understanding of Addiction and Its Treatment

Lorman Education Services

In this on-demand webinar, you will be learning a new way to both understand and treat addiction - a way that has been revolutionizing the field. Described by scholars and clinicians as masterful, pioneering and courageous, this new approach has enabled successful treatment of patients who have been unable to do well in any previous therapy. Based on clinical work with thousands of patients and publications by Dr. Dodes in major academic journals and his popular books, The Heart of Addiction, Breaking Addiction: A 7-Step Handbook for Ending Any Addiction, and The Sober Truth: Debunking the Bad Science Behind 12-Step Programs and the Rehab Industry; this webinar has received acclaim from clinicians in 15 states. Previous attendees have described the influence on their clinical work as profound and deeply satisfying to them in their efforts to help their patients suffering from addictions.
Watch Now

How to Leverage Clinical IRT to Improve Clinical Trial Efficiency

Sharp Clinical Services

In this live webinar, our featured speaker will focus on the many attributes that must be considered to improve your clinical trial efficiency and experience. Participants will learn how to use the information you have from the protocol and clinical trial knowledge, along with clinical IRT expertise to ensure that the simple or complex randomization scheme is properly designed and set up to ensure flawless execution. As clinical trial success rests on delivering the right clinical treatment at the right place at the right time, the speaker will also illustrate supply chain optimization techniques which can be used as variables within clinical IRT to ensure this basic requirement is met.
Watch Now

Spotlight

resources