Resources

Pharmaceutical Technology spoke with Regulatory Compliance Associates about receiving an FDA 483 and developing a corrective action and preventive action (CAPA) plan. PharmTech: What are the best practices for developing...

Q. I have been hearing that regulatory authorities are beginning to audit companies regarding their ‘quality’ culture's relationship to data integrity tools. Can you give me a little background on...

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...