Curriculum
- 4 Sections
- 20 Lessons
- 1 Day
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- Foundations of Cleaning Validation5
- 1.1What is Cleaning Validation (CV) and why it is critical?
- 1.2Regulatory expectations: USFDA, EMA, WHO, PIC/S
- 1.3Key concepts: MACO (Maximum Allowable Carryover), Acceptance Criteria, Swab vs. Rinse Sampling, Recovery Studies
- 1.4Control strategies & lifecycle approach in CV
- 1.5Quick Quiz: Wrong CV definition – testing conceptual clarit
- Strategies for Effective Cleaning Validation5
- 2.1Best strategies: Risk-based approach, grouping & bracketing, matrixing
- 2.2Setting acceptance criteria – therapeutic dose, LD50, 1/1000 of minimum daily dose
- 2.3Common approaches: worst-case product, equipment, and process selection
- 2.4Pitfalls in industry practice – over-reliance on visual inspection, inadequate sampling, misaligned limits
- 2.5Case Discussion: Compare a successful vs. failed CV strategy from industry
- Real-World Failures & Lessons Learned5
- 3.1Case studies from USFDA 483s & EU inspection findings.
- 3.2Examples of contamination recalls due to inadequate cleaning validation.
- 3.3Where companies fail: inadequate documentation, lack of risk assessment, non-aligned protocols.
- 3.4Role of QbD (Quality by Design) and risk-based thinking in avoiding failures.
- 3.5Case Analysis: Participants analyze a real inspection observation and propose corrective actions.
- Building Robust Cleaning Validation Programs5
- 4.1Designing effective protocols and SOPs
- 4.2Integration with QMS, change control, and CAPA
- 4.3Tools & approaches: V-model/W-model for validation, lifecycle approach
- 4.4Emerging technologies: PAT (Process Analytical Technology), automation, rapid microbiological methods
- 4.5Exercise: Participants work in teams to draft a CV strategy for a hypothetical multi-product facility, balancing compliance, cost, and risk
Regulatory expectations: USFDA, EMA, WHO, PIC/S
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