GLP in the Bioanalytical Lab – An Intended Purpose Approach from Good Science towards Compliance.
By Christopher Tudan, Ph.D.

The objective of the course is to provide in-depth training on the “Intended Purpose” approach to Bioanalytical Method Development and Validation as supported by the Guidance, recent Crystal City meetings and pertinent white papers. I will lead (and support) discussions on the currently accepted concepts and criteria for the development and validation (or qualification) of bioanalytical methods that are GLP/GCP compliant. Specific case studies and raw data examples are used to illustrate method development strategies and successful implementation of validation efforts towards rapid, robust and compliant validation processes. Part 11 is also a most relevant topic of this section. Although the focus of the discussions will be LC-MS/MS directed, an equal balance of examples and important perspectives associated with the validation of Ligand Binding Assays will also constitute an important component of the course, as well as other current technologies including ICP-MS, biomarkers, qPCR and DBS. Finally, effective approaches to the technical review of raw data, including the acceptance and rejection of data, will be discussed to cement the points considered earlier in the day. The trends in global bioanalytical method validation (BMV) will be discussed throughout to account for the current Global Harmonization of BMV guidances initiative.

Program Outline:

1. FDA Guidance Recommendations for Method Validation.
2. Validating a Bioanalytical Method:
1. Method Validation performance characteristics
1. LC-MS/MS
2. Immuno-assays [LBA, ADA, Biomarker]
2. Method Development Considerations - Recommendations/Strategies to Facilitate a Rapid and Compliant Validation Process.
3. Validation Experiments
1. LC-MS/MS
2. LBA
3. Applicable technologies: IPC-MS, qPCR, DBS, Flow
4. Validation Acceptance Criteria – Today’s standards (current expectations)
5. BA Validation parameter requirements – Addressing test requirements and criteria of each Validation experiment
6. Matrix Effects versus Recovery
7. Reference Standards
8. System Suitability
3. Partial versus Cross Validations – Changes in Validation Parameters versus Respective Minimal Experimental Requirements and Criteria.
4. Mass Spectrometry for the Layperson
Reviewing LC-MS/MS Raw Data? - Interpreting Chromatography, Scans, Spectra, Response Measures and Method Parameters that Impact the Data.
5. Part 11 and Bioanalysis
1. The Predicate Rule
2. 483’s / Warning Letter Examples
6. Acceptance / Rejection of Data.
7. Validation Report Components.
8. Bioanalytical Study Plans.
9. Final Discussions and Exchange of Experiences and Perspectives.