QA/QC Featured Articles

1. Is Your Definition Of Quality Culture The Same As The FDA's? 1/19/2021

   Steven Niedelman and Christina Markus boast more than 70 collective years of pharmaceutical regulatory experience, which will be on full display when they tell you where your quality culture may be falling short at the upcoming FDA/Xavier PharmaLink conference in March. Here’s a sneak peek.

2. 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.

3. 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. 

4. Inside FDA’s AI-Based Established Conditions Pilot 4/1/2020

   FDA-CDER’s Geok Yan Loo gave us an inside look at CDER’s application of artificial intelligence to inform and improve pharmaceutical quality systems. The pilot offers good reason to consider how machine learning can improve bioprocessing quality and ease your regulatory burden.

5. Update On Advanced Rapid Microbiology Methods In Biopharma 2/13/2020

   A BioPhorum survey of biopharma end-users reveals the opportunity—and the challenge—involved in the adoption of advanced rapid microbiology methods. Audrey Chang, global head of development services at BioReliance Merck; Morven McAlister, senior director at Pall Biotech; and Scott Hooper, associate director at Merck & Co Inc. break down the data.

6. How To (Better) Identify And Analyze Trends In Your Bioprocessing Operations 8/15/2018

   This is the first in a five-part article series, Identifying And Resolving Errors, Defects, And Problems Within Your Organization. This article will enhance your understanding and prime you for visual detection of real trends in your organization by looking at a couple of examples.

7. 4 Key Takeaways From The ISPE/FDA/PQRI Quality Manufacturing Conference 6/12/2015

   Continuous manufacturing, drug shortages, and more were key themes at this year’s ISPE/FDA/PQRI Quality Manufacturing Conference. Here’s what some of the pharmaceutical industry’s leading minds had to share on these topics.

8. 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. 

9. 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. 

10. 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.