Training

In addition to our major conferences, we offer training that builds a strong foundation that enables each organization to implement changes needed to successfully meet FDA expectations.

FDA Safety and Innovation Act

The FDA Safety and Innovation Act (FDASIA) is more than just a user fee schedule: there are other provisions that will change your manufacturing and product approval processes. Significant changes to law affecting FDA regulation have not occurred in over a decade and will have an impact on the Pharmaceutical Industry. These new requirements go into effect in 2013, are you prepared? Learn more »

Advanced Risk Management

Our Advanced Risk Management course is customized to meet your needs. On day one, participants bring with them process maps that are discussed, debated and enhanced during small-group sessions. The groups work to ensure all activities—key stakeholders, metrics and risks—are identified on the process map. Find out more »

FDA Pre-Approval Inspection Program

Position your company for FDA readiness. This intensive training provides you with an understanding of why the FDA conducts the pre-approval inspection the way it does, its goals, how the inspection is conducted and how you can to build compliant systems throughout every stage of your product's lifecycle. You conduct research, work in small groups, present findings and develop action plans to establish inspection readiness. Find out more »

ICH Triple Qs

ICH Q8 (Quality by Design), ICH Q9 (Risk Management) and ICH Q10 (Quality Systems) are guidance documents critical for the pharmaceutical industry to understand and actively implement. Many training courses discuss the intricacies of each guidance separately. Ours training is different. We include all three together. Why? Quite simply, they are interdependent. Find out more »

OOS Boot Camp 

Poor investigations result in the most highly cited finding made during FDA inspections. Training courses on how to develop your OOS Standard Operating Procedures and improve your scientific writing typically do not seem to work. So what does work? Xavier's OOS Boot Camp. Find out more »