CAPA Featured Articles
-
New Podcast: Building Blocks Of The Biopharma Business
4/21/2020
We just launched the first full episode of the Business of Biotech podcast, a series purpose-built for the leaders of new and emerging biopharma companies. Here’s a recap of the first episode with industry icon Allan Shaw, highlighting the season to come and offering some strategic, straightforward advice for new biopharma leaders.
-
Introducing The Business Of Biotech Podcast
4/17/2020
BioProcess Online is proud to launch The Business Of Biotech, a podcast series dedicated to the leaders of new and emerging biopharma firms as a resource on their journey from drug discovery to success in the clinic. Here's a preview of our first season, stacked with insight from founders who have done just that.
-
The CAPA Detective
9/16/2015
Every industry has its detectives. Mechanics and journalists hunt for leaks. Software testers and security experts look for bugs. Meteorologists, defense strategists, and forensic accountants all look for trouble brewing off shore. The level of intrigue may vary.
-
Drug Shortages Highlight Quality Problems
6/5/2015
On the same day the Wall Street Journal published an article highlighting the issue of drug shortages in the US, CDER Director, Dr Janet Woodcock, delivered a keynote at the ISPE Quality Manufacturing Conference. Dr. Woodcock discussed initiatives by the FDA to overcome issues with manufacturing quality, a leading reason for drug shortages in the US.
-
Quality Risk Management: Reduce Risk By Embracing It
5/26/2015
Despite the resources available to help companies develop a QRM program, such as the ICH Q9, there are several challenges that commonly prevent a successful implementation. Ghada Haddad, director in global sterile and validation at Merck, suggests several best practices that can help overcome these issues.
-
Quality Takes Center Stage At ISPE Event
5/20/2015
As the pharmaceutical landscape continues to change and evolve, it is up to you to not only determine how to raise the bar for innovation but also do so with the utmost focus on quality. If you take a look at the ISPE/FDA/PQRI Quality Manufacturing Conference agenda, attendees will see this is an opportunity to learn how to accomplish just that.
-
Pilgrim Software's 10th Global Customer Conference Lauds 'Success Through Quality'
4/23/2014
Pilgrim Software, Inc., a leading provider of cloud and on-premise enterprise quality management solutions, hosted its tenth worldwide customer conference this month.
-
How Reliable Is The Pharma Equipment You Buy?
8/13/2013
When it comes to equipment manufacturing in the pharmaceutical industry, it is imperative that a product functions exactly as it was intended. Any misstep caused by faulty equipment could have catastrophic results for the company that produces a drug, but more importantly, for the patient who uses it. The serious consequences that can result from a lack of accurate equipment design and the associated manufacturing processes are why Donald Dobert, president and COO of ATL Pharmaceutical/Medical, created his company’s New Product Development (NPD) Planning Process.
-
Growing Freight Tonnage Equals Growing Cargo Security Concerns
6/14/2013
The ability to track the location of cargo is always an important requirement for shippers; however, tracking not only the location of cargo but also monitoring cargo security is perhaps more important. It’s simple to just check the location of a shipment, but do you know if your cargo is truly secure?
-
Is Your Document Control System Out Of Control?
5/13/2013
Document control is always an interesting topic for discussion. It seems like a simple topic and area for compliance, but I often run into companies with document control systems that are overly complicated and difficult to manage. By Christine Park, Quality Architech