Resources

Developing Effective CAPA Plans After an FDA 483 This article addresses best practices for developing a corrective and preventive action (CAPA) plan following an FDA 483. A well-designed CAPA system...

Quality Culture and Data Integrity This article examines the growing connection between an organization’s quality culture and the integrity of the data generated to support pharmaceutical product quality. Regulatory authorities...

Q: How much CAPA data do I need to support opening a corrective and preventive action investigation? A: This is an interesting question because it raises the issue of whether...

In recognition of Quality Week, we will be hosting a special quality culture webinar featuring industry leader Susan Schniepp. She will cover the beginnings of the FDA quality metrics initiative,...

Optimizing Your Quality Management Program to be FDA compliant. This FDAnews virtual summit webinar can empower your team to develop a world-class QMS by implementing the essentials of quality management...

A recently registered 503B Sterile Outsourcing Facility was facing serious enforcement action from the FDA. Under RCA's guidance, the company became one of the first outsourcing facilities to remediate FDA's...