Analytical Method Validation Interactive Workshop to Assure Your Test Results Pass FDA Scrutiny
Product Details
Now there's a hands-on workshop where participants can learn how to do the actual work — write the protocols, ensure readiness prior to execution, and then execute — under the supervision of a qualified expert.
Drug and biologics manufacturing is a job for perfectionists.
Thousands of analytical tests are at its heart — sometimes tens of thousands — that must be validated and/or verified according to strict FDA protocols and international regulatory agency expectations.
The decision to release product is based solely on data ... data that are generated from tests. The consequences are significant and there's no room for mistakes.
When errors do slip through, poor quality products can cost companies millions in recalls — and even more in losses from fines and sanctions, product delays or withdrawals, wasted effort and lost profits.
Proper training is key. But as drug science grows ever more complex, even the best-trained analysts quickly lose their edge.
What's needed is a hands-on workshop, a safe place where participants can do the actual work — write the protocols, ensure readiness prior to execution, then execute — under the supervision of a qualified expert.
Such a workshop exists — and it's coming soon to Boston and Raleigh. Mark your calendar now for Analytical Method Validation: Interactive Workshop to Assure Your Test Results Pass FDA Scrutiny.
From start to finish, you'll have the how-to’s of running analytical method validation, including the generation and compilation of data reports.
Register now and you will:
- Hear nine key method validation characteristics
- Learn the five analytical method validation pitfalls
- Discover 15 critical points, from start to finish, for analytical method validation
- Understand the regulatory expectations for analytical method validation protocols
- Review the six key elements of an analytical method validation plan
- Recognize 10 analytical method validation protocol key elements
- Identify 16 items that must be documented in an analytical method validation summary report
- Know the steps to take to ensure validation prerequisites, such as analytical instrumentation qualification, operation qualification and performance qualification, are identified and met
- Distinguish between requirements for qualification versus validation and know when a qualification is applicable and when a validation is required
- Recognize the signs that indicate when a revalidation is required following modifications to test method and discover what you must do if you decide not to revalidate
- Listen to seven real-world method modification examples, the decision process for revalidation and the key elements for executing the protocol
- Have five method optimization points to consider
- Understand the minimum requirements for determining precision, intermediate precision (ruggedness) and robustness
- Realize what is expected when determining accuracy and the three methods for doing so
- Discover five important points when determining specificity
- Understand specificity versus selectivity
- Know key expectations for detection limit and quantification tests
- Determine what is and is not acceptable in linearity and range
- Conduct solution stability and stress testing
- Clarify the requirements for identifying and documenting test results
- Assemble all results into a final validation report and package
You'll not only get step-by-step instruction on executing an analytical method validation, but you'll have the chance to perform your own method validation summary report and share the results with your peers and with Michele Piepoli, your expert instructor.
You'll come away from this new interactive workshop fully prepared to write a comprehensive analytical method validation summary report that will pass FDA muster.