• Where data fits in the analytical workflow: sample → instrument → data system → report → decision
• Why most non‑conformities are data‑related, not instrumental
• Legal and regulatory implications of poor data handling
• ISO/IEC 17025 clauses relevant to HPLC data: data integrity, technical records, uncertainty, reporting, non‑conforming work
• (Online clause‑to‑practice mapping exercise)

• What constitutes raw HPLC data: chromatograms, detector signals, instrument parameters, sequence tables, audit trails
• Data acquisition best practices: sequence design (blanks, standards, QC, samples), injection order rationale, avoiding carryover and drift
• Electronic data systems (CDS): user access control, audit trails and metadata, backup and archival expectations

• Understanding the chromatogram: baseline, noise, drift, peak height vs area, resolution
• Peak identification criteria: retention time matching, relative retention time (RRT), peak purity (PDA), matrix interference recognition
• Common interpretation pitfalls: ghost peaks, co‑elution, baseline disturbances, misidentification in complex matrices
• (Virtual chromatogram interpretation cases)

• Integration fundamentals: automatic vs manual, integration parameters, justification for manual integration
• ISO 17025 expectations for integration: traceability of changes, audit trail review, consistency across batches
• Re‑integration and reprocessing rules: when allowed, documentation, supervisor review
• (Online integration and reintegration exercise)

• Calibration strategies: external standard, internal standard, standard addition
• Calibration curve evaluation: linearity, working range, weighting factors, acceptance criteria
• Quantitative calculations: response factor, sample concentration, dilution and recovery corrections

• Precision and trueness: repeatability, intermediate precision, bias evaluation
• Detection and quantification limits: LOD/LOQ approaches (S/N, statistical), matrix‑specific considerations
• Measurement uncertainty: identifying sources, bottom‑up vs top‑down, reporting uncertainty
• (Interactive uncertainty estimation exercise)

• System suitability tests (SST): retention time, resolution, tailing factor, theoretical plates
• Ongoing QC samples: blanks, spikes, control samples, control charts
• Handling QC failures: immediate actions, root cause analysis, documentation per ISO 17025

• ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available
• Preventing data integrity breaches: unauthorised access, manual transcription errors, selective reporting
• Audit readiness: preparing data packages, responding to auditor queries, common audit findings

• Identification vs quantification confidence – criteria for positive identification, borderline results
• Regulatory and client‑driven interpretation: compliance with limits, statements of conformity, decision rules
• Handling non‑conforming results: OOS, OOT, CAPA

• Mandatory elements of an HPLC report: sample ID, method reference, test results/units, uncertainty, conformity statement, authorisation
• Matrix‑specific reporting considerations: food/feed, environmental, pharmaceutical, biological
• Common reporting errors: missing uncertainty, ambiguous units, unsupported conclusions
• (Online report‑writing exercise)

• Impact of changes on data: column replacement, software updates, instrument maintenance
• ISO 17025 documentation: change justification, re‑verification requirements, communication with clients
• Online practical component: end‑to‑end dataset (raw chromatograms → final report), peer technical review simulation, auditor‑style review, drafting CAPA for data‑related non‑conformities