Course Level:
Advanced / Professional / Regulatory
Course Duration: 4 Hrs. (Online)
Course Access & Completion Guidelines
- After successful fee payment, participants are required to register and create an account on learning portal (learn.uyirgene.com)
- Upon registration, course access will be activated, and a confirmation email will be sent to the registered email ID.
Program Structure
- Participants must complete all chapters sequentially
- A final assessment must be completed after finishing all modules
- Examination Completion Deadline: Within 1 Month
- All course materials are available for download directly from the portal
- Upon successful completion of the program and assessment, participants will receive: “Professional Skills Certification Aligned with International Standards”
- The certificate can be downloaded directly from the portal after completing the examination.
Certificate in Bioanalytical Method Validation & Study Sample Analysis
Course Description
This self-paced professional training program is designed to provide a clear and practical understanding of LC–MS/MS bioanalytical method validation in compliance with ICH M10, US FDA, and EMA regulatory guidelines.
The course covers core validation parameters, regulatory expectations, and best practices followed in CROs, pharmaceutical companies, and bioanalytical laboratories. It is ideal for learners who want to build a strong foundation in bioanalytical method validation without requiring prior extensive industry experience.
Through structured video modules, real-world explanations, and regulatory insights, participants will gain the confidence to understand, interpret, and support LC–MS/MS validation activities in regulated environments.
- (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 “Professional Skills Certification Aligned with International Standards”.
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