Resources

Q. I'm a new employee for a start-up company and have been tasked with writing the quality manual for my company. I have searched but have been unable to find...

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...

The growth and globalization of the pharmaceutical supply chain make risk assessment more important than ever for pharmaceutical manufacturers. The authors describe a program to identify, prioritize, mitigate, and communicate...

When in-person training may not be feasible, there are still pharma courses that can ensure employees receive the required career development, says Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates....