Framework of a Validation Report
12/25/2018
Category: Good Industry Practices
The U.S. FDA is clear that medical devices and/or significant processes must be validated to ensure the standard of quality is being...
Read More
Initial Pediatric Study Plan (iPSP)
12/17/2018
Category: Good Industry Practices
For over 20 years, FDA has promoted the pursuit of increased information and the study of pharmaceutical products in pediatric patients. This...
Read More
Quality Control vs Quality Assurance
12/03/2018
Category: Good Industry Practices
Quality is key to any successful business. Quality ensures standards are being met in processes or products. Companies involved in pharmaceuticals, biologics,...
Read More