Visualizing Quality Culture Data – Analyzing 2 Scenarios
The following article is taken from June 15th Webinar – “Create a Quality Culture data to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives”. Challenges of Weak or Ambiguous Quality Culture Data Now let’s look at a third quality culture scenario, where you have a weak or ambiguous culture. Notice in this one that […]
Reducing Supply Chain Risk with a Scorecard Approach
Global supply chains can be disrupted in many ways, including geopolitical instability, environmental disasters, regulatory non-compliance, and financial instability. To mitigate these risks, companies must proactively assess the vulnerability of their suppliers and manufacturing plants. One of the most effective tools for this is a supply chain risk scorecard that systematically evaluates key risk factors […]
Integrated Quality Assurance Systems: Clinical Trials
The notion that the role of Integrated Quality Assurance Systems in clinical development should be relegated to reviews, audits, and quality control (QC) checks is an old-fashioned one. This could well run medical product developers afoul of FDA and international regulations. The Role of Quality Assurance (QA) in Clinical Trials The role of QA in […]
PMWS24: Agile Manufacturing and Patient-Centricity
Since 2021, the Pharma Manufacturing World Summit has gathered SVPs and VPs of Manufacturing, Quality, Supply Chain, Technical Operations Executives, and other industry professionals. These industry leaders are responsible for making pivotal decisions that shape the pharmaceutical industry’s future. This year, speakers placed an emphasis on covering new topics that highlighted agile manufacturing and patient-centricity. […]
GxP Best Practices Part 4: Regulatory Compliance Risks
In session 4 of our Executive GxP Training program, Teresa Gorecki discusses understanding and managing the regulatory compliance risks to your business. The two provide an overview of the FDA’s history and the consequences of non-compliance and what assuming too much compliance risk can do to your business. Formation and Purpose of the FDA The […]
Quality Culture: What Are the FDA’s Thoughts?
Quality culture, a term that has been gaining traction in regulatory compliance, is taking center stage in the life sciences industry. In a recent webinar below, industry experts discussed the FDA’s growing interest in quality culture (QC) and its pivotal role in ensuring the success and safety of pharmaceutical and medical device products. Before diving […]
How Has Biopharmaceutical Risk Changed in Light of Recent Events?
Risk is still an important issue, and the fundamental premise is that there is so much to do. With this important issue and ever-changing landscape, biopharmaceutical risk is constantly evolving and requires immediate attention. The science is so complex. The regulatory environment is so complex. The business operating environment is so complex that companies can’t […]
Risk Management and Data Integrity: Focusing on the Critical
The FDA has long taken a risk-based approach to manufacturer GMP compliance expectations and enforcement actions, as well as requiring pharmaceutical and medical device manufacturers to do the same in their quality system operations. Similarly, companies can also use risk management approaches to rapidly reduce organizational risk in their data integrity efforts, by directing their […]
