Process Validation and Continued Process Verification

Programme Summary

Build a lifecycle approach to demonstrating that a manufacturing process can consistently meet defined requirements. Participants connect process knowledge, qualification planning and continued performance review through a realistic production case. Exercises develop acceptance criteria, sampling rationale and deviation responses, helping teams create validation evidence that reflects actual process risks instead of relying on a fixed number of successful batches.

Training Objectives

1 Connect process knowledge with validation strategy; 2 Define risk based qualification and acceptance evidence; 3 Plan representative sampling and performance evaluation; 4 Manage deviations and continued verification activities; 5 Strengthen lifecycle change and review decisions.

Learning Outcomes

1 Prepare a process validation strategy; 2 Define critical parameters and quality attributes; 3 Draft a qualification protocol with criteria; 4 Evaluate a deviation and validation conclusion; 5 Design a continued process verification plan.

Target Audience

Validation Engineers; Process Engineers; Manufacturing Scientists; Quality Assurance Managers; Production Technical Managers.

Target Industries

Pharmaceutical Manufacturing; Biopharmaceutical Manufacturing; Medical Device Manufacturing; Specialty Chemical Manufacturing; Contract Manufacturing.

Course Contents

• Module 1 Lifecycle Validation Strategy: Intended process output and customer requirements; Process design qualification and ongoing verification; Risk proportional evidence and responsibilities.
• Module 2 Process Knowledge: Material attributes and process parameters; Sources of variation and failure mechanisms; Development evidence and knowledge gaps.
• Module 3 Criticality and Control Strategy: Quality attributes and parameter relationships; Risk based control selection; Monitoring limits and preventive arrangements.
• Module 4 Facilities and Equipment Readiness: Design suitability and installation evidence; Operating range and control functionality; Measurement calibration and system readiness.
• Module 5 Qualification Protocol Design: Objectives scope and justified acceptance criteria; Responsibilities resources and execution sequence; Data integrity and protocol approval.
• Module 6 Sampling and Statistical Rationale: Representative conditions and variability coverage; Sample size and measurement suitability; Avoiding arbitrary batch count assumptions.
• Module 7 Executing Qualification Studies: Documented operating conditions and observations; Controlled deviations and technical investigation; Data checks and evidence preservation.
• Module 8 Evaluating Performance: Comparison with predefined acceptance criteria; Variation stability and capability considerations; Uncertainty and evidence sufficiency.
• Module 9 Validation Report and Release: Results deviations and scientific conclusions; Residual risks and outstanding action conditions; Authorised decisions and traceable reporting.
• Module 10 Continued Process Verification: Ongoing measures frequencies and review ownership; Trend signals and adverse performance response; Maintaining a controlled validated state.
• Module 11 Change and Revalidation: Material equipment method and scale changes; Impact assessment and additional evidence needs; Periodic review and knowledge updates.
• Module 12 Validation Case Workshop: Drafting a risk based qualification protocol; Evaluating supplied performance and deviation data; Presenting a lifecycle verification recommendation.

Assessment

• 60 single best answer questions, including applied scenarios; one mark per question.
• 90 minute invigilated digital examination with identity verification. Approved accessibility adjustments preserve the assessed competence.
• Supplied reference pack and calculator permitted; external internet and AI prohibited.
• Individual applied assessment (45 minutes): Prepare a qualification protocol and continued verification plan, then evaluate a supplied deviation and justify whether the evidence supports the stated process use.
• Assessment criteria: Risk based protocol and acceptance design; Sound data and deviation interpretation; Practical lifecycle monitoring and change controls.
• Pass each component separately: 45/60 written marks (75%) and at least 70% on the applied task.
• Individual results and feedback are provided. One reassessment may follow coaching under the published enrolment terms.

Certification

• Successful learners receive a TQCSI Arabia digital Certificate of Successful Completion.
• The certificate records the learner name, exact programme title, teaching hours, completion date and unique verification reference.
• Verified identity, full attendance and separate written and applied passes are required; all mandatory critical criteria must be met.
• Proposed issue target: within 30 calendar days of approved results and settlement of applicable fees.
• Records process validation planning skills; it does not validate a production process or authorise regulated product release.
• Attendance confirmation may record completed hours for unsuccessful learners; it does not certify successful completion.

Programme Profile

Number of daysNumber of daysNumber of days

333

Total teaching hoursTotal teaching hoursTotal teaching hours

18 hours; breaks, pre course work and formal final assessments excluded.18 hours; breaks, pre course work and formal final assessments excluded.18 hours; breaks, pre course work and formal final assessments excluded.

Delegates allowedDelegates allowedDelegates allowed

Maximum 16 delegates.Maximum 16 delegates.Maximum 16 delegates.

Training prerequisitesTraining prerequisitesTraining prerequisites

Manufacturing process or quality experience and basic statistics are required. Familiarity with production controls and technical specifications is essential.Manufacturing process or quality experience and basic statistics are required. Familiarity with production controls and technical specifications is essential.Manufacturing process or quality experience and basic statistics are required. Familiarity with production controls and technical specifications is essential.

Pre course assignment and assessmentPre course assignment and assessmentPre course assignment and assessment

Review a fictional manufacturing process and performance history for 30 minutes; identify critical characteristics and uncertainty.Review a fictional manufacturing process and performance history for 30 minutes; identify critical characteristics and uncertainty.Review a fictional manufacturing process and performance history for 30 minutes; identify critical characteristics and uncertainty.

End of course assessmentEnd of course assessmentEnd of course assessment

60 question written exam (90 minutes) and individual applied task (45 minutes).60 question written exam (90 minutes) and individual applied task (45 minutes).60 question written exam (90 minutes) and individual applied task (45 minutes).

Passing criteriaPassing criteriaPassing criteria

75% written and 70% applied, passed separately; full attendance.75% written and 70% applied, passed separately; full attendance.75% written and 70% applied, passed separately; full attendance.