Outcomes from 483 Observations
One of the outcomes from a poorly handled 483 response is that the severity of the enforcement...
Read More
Author: Nigel J Smart PhD
What’s involved with 483 Observations
Upon inspecting your pharmaceutical facility, the FDA will issue a 483-observation report if there...
Read More
Development validation Programs for Biopharmaceutical Companies
The development of a strategy for the commissioning of facility and equipment systems to support...
Read More
The importance of KPI’s in the improvement of Pharmaceutical Quality Compliance
Key performance indicators (KPI’s), are very important mechanism for promoting continuous...
Read More
Nigel today at the American Outsourcing Event, Crown Plaza Hotel, Cherry Hill NJ
Nigel today at the American Outsourcing Event, Crown Plaza Hotel, Cherry Hill NJ
Read More
Testimonial
Smart Pharmaceutical Consulting has made a major contribution to our manufacturing strategy and how we plan to operate our plant in the future.