Course Level:
Advanced / Professional / Regulatory
Course Duration: 4 Hrs. (Online)
- Liquid Chromatography–Mass Spectrometry (LC–MS/MS) Bioanalytical Method Validation & Study Sample Analysis training courses Class Room Link / Training Link will be shared through your registered email after the completion of the fee payment.
- Participants need to go through the Each chapter and complete the final assessment.
- Duration of the Program: (4 Hrs.)
- Examination should be completed within One Month.
- Course materials can be downloaded from the classroom.
- Upon completion of the course, participants gain the INTERNATIONAL CERTIFICATE
Certificate in Bioanalytical Method Validation & Study Sample Analysis
- (ICH M10 Aligned | Self-Paced Fast Track)
- Total Duration: 3–4 Hours
- Mode: Self-paced (video + reading + quiz)
- Level: Advanced / Regulatory
- Certification: Yes (Online Exam)
COURSE OBJECTIVE (Fast-Track)
By the end of 4 hours, learners will be able to:
- Understand the full bioanalytical lifecycle (development → validation → study analysis)
- Apply ICH M10 acceptance criteria correctly
- Make regulatory-defensible decisions during runs, failures, and reanalysis
- Pass CRO interviews / internal certification / regulatory audits
Target Audience
- Bioanalytical Scientists
- LC–MS/MS & LBA Analysts
- CRO Analysts & QA
- Clinical Pharmacokinetic Professionals
- Regulatory Affairs & Compliance Teams
MODULE 1: Bioanalytical Method Development (Foundation)
- Purpose of bioanalytical method development
- Analyte characterization:
- Physicochemical properties
- Metabolism & distribution
- Protein binding
- Method limitations and readiness for validation
- Difference between development and validation documentation
MODULE 2: Bioanalytical Method Validation Types
- Definition of bioanalytical method
- Full validation:
- When required
- Chromatographic vs LBA elements
- Partial validation:
- Cross validation:
- Multi-lab / multi-method scenarios
MODULE 3: Selectivity & Specificity
- Selectivity:
- ≥6 matrix sources
- Acceptance criteria (20% / 5%)
- IS selectivity
- Lipemic and hemolyzed matrix evaluation
- Specificity:
- Metabolites, isomers, impurities
- LC-MS/MS strategies
- Back-conversion assessment and documentation
MODULE 4: Matrix Effect
- Definition and regulatory impact
- Evaluation design:
- ≥6 sources
- Low & high QCs (triplicate)
- Special populations
- Acceptance criteria
MODULE 5: Calibration Curve & Range
- Calibration standards design
- Blank vs zero samples
- Regression models and weighting
- LLOQ / ULOQ criteria
- Handling rejected standards
- Reporting requirements
MODULE 6: Accuracy & Precision
- QC preparation principles
- QC concentration levels
- Within-run vs between-run
- Acceptance criteria
- Trending and run-size equivalence
MODULE 7: Carryover
- Definition and causes
- Evaluation after ULOQ
- Mitigation strategies
- Documentation expectations
MODULE 8: Stability Studies
- Matrix stability:
- Freeze-thaw
- Bench-top
- Long-term
- Processed sample stability
- Stock & working solution stability
- Chemical vs biological drug approaches
MODULE 9: Study Sample Analysis & System Suitability
- Timing of validation completion
- System suitability requirements
- Independent samples
- IS response monitoring
MODULE 10: Analytical Run Design
- Run composition
- QC bracketing
- Batch processing rules
- BA/BE-specific considerations
MODULE 11: Acceptance Criteria for Analytical Runs
- Calibration standards acceptance
- QC acceptance rules
- Dilution QC handling
- Multi-analyte decision logic
MODULE 12: Calibration Range Management
- Curve narrowing
- QC modification
- Partial revalidation triggers
- Handling samples above ULOQ
MODULE 13: Reanalysis & Reinjection
- Acceptable reasons for reanalysis
- Prohibited practices (PK-driven reanalysis)
- Reinjection rules
- Documentation requirements
MODULE 14: Chromatogram Integration & Reporting
- Integration vs reintegration
- Manual integration controls
- BA/BE submission requirements
- Bioanalytical Report expectations
CERTIFICATION EXAM
Exam Format
- Total Questions: 50
- Duration: 60 minutes
- Passing Score: 70%
Outcome: Participants completing the Liquid Chromatography–Mass Spectrometry (LC–MS/MS) Bioanalytical Method Validation & Study Sample Analysis Training Program will be equipped to plan, conduct, report effectively. They will gain the INTERNATIONAL CERTIFICATE.
Course Duration:
- SELF-PLACED COURSE (Do not Wait ! Start Now !)
SELF-PLACED COURSE ( Do not Wait! Start Now !)
- After fee payment we will share the Self-Placed Course Link to your registered email address.
- After receiving mail join the class and start learn and complete the assignment and examinations.
- U-TECH INTERNATIONAL certificate of “Liquid Chromatography–Mass Spectrometry (LC–MS/MS) Bioanalytical Method Validation & Study Sample Analysis” will be issued to participants only after successful completion based on written examination
Training Link: Will be shared through your registered email after the completion of the fee payment.
CERTIFICATION
• U-TECH certificate of “Liquid Chromatography–Mass Spectrometry (LC–MS/MS) Bioanalytical Method Validation & Study Sample Analysis” will be issued to participants only after successful completion based on performance during the course and in written examination
• Others who have not successfully completed the course will be issued a certificate of attendance.
Training Link: This will be shared through your registered email after the completion of the fee payment.
Course materials will be provided for all participants