Program Overview
This intensive one-day program equips participants with deep insights into applying Quality by Design (QbD) concepts to cleaning validation in regulated industries. Delivered by an industry veteran with 25+ years of experience, the course blends conceptual clarity, real-world inspection cases, and hands-on simulations. Participants will learn how to design risk-based cleaning strategies, optimize processes through DoE and statistical tools, address analytical and operational challenges, and align practices with global regulatory expectations (USFDA, EMA, WHO, PIC/S). The program emphasizes practical problem-solving and equips teams to strengthen compliance frameworks while minimizing cross-contamination and audit risks.
Features
- Apply QbD principles to design robust and risk-based cleaning validation strategies.
- Identify common challenges, pitfalls, and regulatory expectations in cleaning processes.
- Use lifecycle approaches, risk assessment tools (FMEA), and DoE for effective validation.
- Develop practical solutions, SOPs, and audit-ready frameworks for compliance.
Target audiences
- QA/QC Professionals
- R&D Professionals
- Validation Professionals
- Manufacturing Professionals
- Engineering Teams
- Regulatory Affairs Professionals
Curriculum
- 5 Sections
- 22 Lessons
- 1 Day
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- Foundations of Cleaning Validation in a QbD Framework4
- Designing Cleaning Processes with QbD Principles5
- 2.1Risk-based design of cleaning procedures.
- 2.2Defining acceptance criteria (MACO – Maximum Allowable Carryover, PDE – Permitted Daily Exposure).
- 2.3Linking cleaning validation to product/process lifecycle.
- 2.4Statistical tools & DoE (Design of Experiments) in cleaning process optimization
- 2.5Case discussion: Failures due to poor design and lessons learned.
- Practical Challenges & Pitfalls in QbD Application5
- 3.1Variability in residue detection (swab vs rinse sampling).
- 3.2Analytical method challenges: LOQ, sensitivity, recovery rates.
- 3.3Handling multi-product facilities & shared equipment.
- 3.4Cross-contamination risks and inspection red flags.
- 3.5Real-world case studies: USFDA 483s and EU inspection observations.
- Lifecycle Approach & Risk Management in Cleaning Validation5
- 4.1Validation vs. Verification: lifecycle perspective.
- 4.2Using FMEA (Failure Mode and Effects Analysis) in cleaning risk assessment.
- 4.3Linking QMS, change control, and continual improvement.
- 4.4Leveraging PAT (Process Analytical Technology) for real-time monitoring.
- 4.5Workshop: Drafting a mini risk-based cleaning validation strategy for a sample product.
- Interactive Exercise3
Instructor
