CAPA Featured Articles

1. 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.

2. 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. 

3. 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.

4. 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. 

5. 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. 

6. 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. 

7. 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.

8. 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

9. Bad Quality Is Contagious: Stop Before It Spreads 1/25/2013

   Disregarding the rules in the regulated industry is like a contagious disease. If you don’t control it in the beginning, you and your organization will be lost. In advanced stages, it could require the termination of many employees with this disease.  When the FDA recommends you hire fresh eyes for quality systems on a warning letter, it actually means your problem is institutionalized. That’s why I recommend a biannual general audit by a third party. Even if you think you can go more than two years without an audit, this bad behavior can grow roots and can infect the quality culture of your organization. Then, when you do receive a visit from the FDA, it will be easier to correct unwanted behaviors and to renew your quality system, if needed. By Rosario Quintero-Vives, Sr. Regulatory & Compliance Specialist, RQV Consulting

10. Implementing A Systemic Approach To Pharmaceutical Quality Systems 1/3/2013

    In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn’t changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations. By Christine Park, Quality Architech