Understanding the Impact of ICH E6 on Your GCP Quality and Compliance Program
Quality Assurance (QA) in Clinical Development has significantly changed over the past two decades. The US Code of Federal Regulations (CFR) initially did not explicitly mandate a system for managing quality throughout all stages of the clinical trial process. However, developing the FDA’s Bioresearch Monitoring (BIMO) Program and subsequent international standards has transformed the landscape […]
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 […]
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. […]
Important GDUFA III Changes: Revisions for ANDA Submissions
In the evolving landscape of pharmaceutical regulation, the recent GDUFA III changes introduced by the FDA promise to enhance the submission and amendment process for abbreviated new drug applications (ANDAs). The FDA has released an updated guidance for the industry titled ANDA Submissions – Amendments to Abbreviated New Drug Applications (ANDAs) Under GDUFA. This revision, […]
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 […]
The Dollar Cost of a Warning Letter: Analyzing the 15% Rule
The New 15% Rule Unfortunately, Warning Letters have become almost a feature of the medical device industry. Not only are they a feature of our beloved industry, but they have also spawned a cottage industry of consultants vying for help resolving them. One key question usually asked of the quality folks involved in a warning letter […]
GxP Best Practices Part 2: Early Stage Tips for Data Integrity
In Teresa Gorecki’s second session of Executive-level GxP training, the two reviewed Regulatory Compliance Fundamentals for Early-Stage Development, emphasizing the importance of data integrity. Evolving Challenges in Clinical Trial Oversight and Data Integrity In clinical trials, US regulations and global regulatory guidelines such as CFR 312 and ICH E6 R2 play crucial roles in ensuring […]
Navigate FDA Warning Letters: 4 Main Causes from John Daley
To navigate FDA warning letters amidst this complex landscape of regulations can often feel overwhelming. With over 3,300 warning letters issued by the FDA since September 2019, including an average of three per month from the Center for Devices and Radiological Health (CDRH), understanding the common pitfalls is more important than ever. If you’re dealing […]
Drug Development: Platform Technology Designation Program
In the ever-evolving landscape of pharmaceuticals, innovation is not just a buzzword but a critical driver of progress. Recently, the FDA introduced a draft guidance for the Platform Technology Designation Program, marking a significant leap forward in drug development and manufacturing efficiency. A Game-Changer for Drug Development The FDA’s Platform Technology Designation Program aims to […]
GxP Best Practices Part 1: Outsourced Operations
In this 4 part series, we are talking through GxP Best practices This article reviews the key highlights from Teresa Gorecki‘s Executive GxP training, Session 1: Differentiating Between Responsibilities and Accountabilities for Biopharmaceutical Companies with Outsourced Operations. In this session, Teresa provides a deeper context for accountability and responsibility for biopharmaceutical companies with outsourced operations. […]
