New drug approval is the Holy Grail, but the path to success may involve thousands — tens of thousands — of tests. And every single one of those tests must pass muster with FDA and other approving agencies, meaning they must be reproducible.
Although regulatory authorities require these tests, they have not produced the most detailed guidance for how to conduct them. FDA, ICH and USP each have expanded method validation requirements in recent years, but they have left to industry how to interpret the regulations.
Come to Tampa in February for two full days of hands-on learning. From the basics to full mastery, this is your opportunity to fill in the blanks in staff training ... and boost your odds for speedy NDA approvals.
Your presenter, Dr. Wayland Rushing, is a recognized expert in analytical drug development requirements. Over the years, Dr. Rushing has overseen development and validation of thousands of methods covering an array of products.
Roll up your sleeves though. This is a hands-on workshop, with plenty of interactive group learning-by-doing. Prepare to discover:
- What analytical method validations are, and their impact on the manufacturing and drug-development processes
- How to design and evaluate analytical method validation — hands-on work sessions with fellow attendees
- Generating and compiling data reports
- Avoiding mistakes and pitfalls
- Testing what you’ve learned
- And much more!
Attendees take home a binder full of materials to refer to again and again:
- Presentation slides and workshop handouts
- Applicable FDA regulations
- Applicable FDA guidances
- Example SOP’s for method validations
- Example validation protocols
- Example validation reports
Tampa is the perfect late-winter break from chilly cold, with daytime highs in the pleasant 70s and nighttime lows trending above 50 degrees. The workshop ends Thursday afternoon, offering an option for a three-day weekend in warm weather.
FDA’s rules must be met. So must those of European and Japanese drug regulators, which require adherence to ICH Q2 (R1) definitions and requirements in submittals and filings. Even sanctions could be a problem: Over the past five or so years, 76 companies have been hit with warning letters for lab control and OOS violations.
When it comes to new drug approvals, there’s no reason to take any sort of risk. This two-day workshop offers much-needed training that pays off — in speedier NDAs, greater patient safety, fewer sanctions.