ARTICLES BY JUDY CARMODY

• How “Two People With A Molecule” Can Build A Quality Culture

  Robert Lutz, Ph.D., is chief science officer of Iksuda Therapeutics, a 20-person start-up developing new antibody drug conjugates (ADCs) to target difficult-to-treat cancers. With an extensive background in ADC development, he believes that building mature quality capabilities is what your company must do every day from day one.

• Think A Quality Culture Doesn’t Affect Your Bottom Line? Think Again

  Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen. News of a pharmaceutical company receiving an FDA Complete Response Letter and Form 483 — citing data manipulation and breaches — drove this point home recently. Based on the FDA observations made in this case, there is clear evidence that components of a voluntary quality assurance (VQA) culture were missing.

• Bridging Chasms In Equipment Qualification And Software Validation

  Equipment qualification seems like a straightforward process. However, things usually go awry when gathering a validation team and defining and documenting the intended use and system requirements. 

• “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019

  Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.

• A Better Approach To Selecting And Overseeing GCP/GLP Vendors And Processes

  This is the third article in a series examining strategies that allow quality groups to collaborate with good clinical practice (GCP) and good manufacturing practice (GMP) divisions to improve compliance, increase clinical study robustness, and enhance data integrity.

• 4 Pitfalls To Avoid When Developing GCP SOPs

  This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.

• 6 Simple Ways To Get Millennials (More) Invested In Quality

  Much has been written about millennials — how they think, what motivates them, and their outlook on life. How can we best prepare them for today’s pharma/biotech manufacturing environment so they are successful?

• 7 Steps To Properly Navigate An Event Investigation

  All information is good information during an event investigation (EI). It is important that the EI is not performed in a bubble — that it is completed in a safe, blameless environment where the community follows specific steps and procedures, and is focused on finding a root cause of a problem rather than conducting a witch hunt. 

• How To Optimize Your Stability Program At Each Phase Of Drug Development [Checklists Included]

  A drug stability program that is above reproach is critical to successfully navigating the complexities of drug development. A well-managed stability program with thoughtfully constructed protocols demonstrates your lab and quality systems are in control.

• How To Bulletproof Your Quality Training Programs

  Lack of proper training remains a systemic problem. However, proper training can ensure that employees integrate quality and agency requirements into everyday activities.

• The 4 Pillars Of A Voluntary QA Culture: How Does Your Company Measure Up?

  How can pharmaceutical companies encourage a quality culture that empowers employees to own quality, so they operate in ways that allow maximum performance and safe, effective products?