Excipients must be evaluated with each drug they are included with to ensure that they can be used safely
Connection between GxP/GMP and document control
Global agencies expectations of analytical equipment qualification along with the development
The participants how to write, maintain, and update SOPs to ensure compliance
Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system.
The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised.
what qualifies a foreign vendor and what disqualifies a foreign vendor
detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC)
We will review how all of this work should be documented
How to apply consistent Meta tags and policies to all documents and records
Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act
Good laboratory practices (GLPs) and good manufacturing practices (GMPs)
Both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning
Understand in detail Computer System Validation (CSV)
for planning, executing or managing the implementation of any system governed by FDA regulations