Cleaning Validation

Achieve Robust Cleaning Programs That Meet Regulatory and Inspection Expectations

Cleaning validation continues to be one of the highest-scrutiny compliance areas in pharmaceutical inspections. From 2000 to 2010, around 25% of FDA Warning Letters cited concerns related to cleaning and cleaning validation. Today, the control of cleaning processes remains a core regulatory priority — not only as a compliance requirement but as a key contributor to manufacturing safety and product integrity.
This course provides a comprehensive understanding of regulatory requirements, practical execution, documentation, and lifecycle management of cleaning validation programs to meet global GMP standards.

Who Should Attend

Professionals responsible for any aspect of cleaning validation

Production and manufacturing personnel

QA and QC personnel handling compliance, deviations, and reporting

Validation and regulatory professionals

Individuals involved in cleaning SOPs, investigations, or inspection readiness

Anyone required to understand the science and lifecycle of cleaning and cleaning validation

Course Objectives

Participants will learn to:

Understand regulatory expectations for cleaning validation related to manufacturing, packaging, and storage equipment

Apply risk-based thinking to cleaning validation strategies

Implement the Cleaning Lifecycle and its associated control programs

Select and interpret analytical methods for measurement of residues

Establish scientifically justified acceptance criteria

Develop, execute, and document cleaning validation protocols

Identify root-cause and resolve cleaning validation deviations

Manage cleaning validation during scale-up, changeover, and investigations

Build compliant cleaning validation files that withstand audits and inspections

Drive continuous improvement in cleaning operations

Course Outline

Cleaning and Cleaning Validation: The Regulatory Imperative

GMP cleaning requirements for drug manufacturing

FDA, EMA and WHO expectations for cleaning validation

ICH Q7 and Q9 considerations during the cleaning lifecycle

FDA trends based on Warning Letters and inspection findings

Applying risk-based control strategies to cleaning and cleaning validation

The Cleaning Lifecycle – A Holistic Approach to Compliance

Development and planning phase

Execution phase

Maintenance and continuous improvement phase

Master Planning for Cleaning Validation

Participants will learn:

How to define acceptance criteria

Protocol requirements and documentation essentials

Strategies to address and resolve deviations

Change control for cleaning validation

Scheduling alignment with manufacturing plans

Communication of results to cross-functional stakeholders

Hands-on Exercise / Demonstration

Cleaning validation protocol development

Interpretation of analytical results

Sample SOP elements related to cleaning validation

Case studies and defect investigation scenarios

Duration

Three days

Key Takeaways

End-to-end practical knowledge of cleaning validation

Ability to develop and execute compliant cleaning validation protocols

Confidence in responding to inspection questions on cleaning programs

Capability to evaluate acceptance criteria scientifically and defend decisions

Strong foundation to maintain a lifecycle-based cleaning validation program

Speak to a Training Specialist

Contact

Building #10, Ground Floor, Business Park, Amman, Jordan
+962 (79) 1533337
m.abuzour@agonme.com

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Services

Management Representative

Training Programs

Cleaning Validation