Presented by
Management Forum
Cleaning Validation - Best Practice in Pharmaceuticals In-house Training
Master the principles of cleaning validation to ensure pharmaceutical manufacturing equipment meets stringent regulatory standards, preventing contamination and safeguarding public health.
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Course overview
Learn how to establish and implement efficient and effective cleaning processes to ensure your equipment and facility are properly cleaned and sanitised before pharmaceutical production.
Pharmaceutical products can be contaminated by other pharmaceuticals, cleaning agents, microorganisms, or various other factors. Such contamination poses significant and serious health risks to the public. To mitigate these risks, standards and guidelines on best practices for the pharmaceutical industry have been established. Cleaning validation is a widely used practice in the industry to ensure these standards are met.
Cleaning validation is essential for the pharmaceutical manufacturing process, ensuring that equipment is adequately cleaned to prevent contamination of subsequent products. Regular monitoring and evaluation of cleaning procedures are necessary to maintain consistent and acceptable performance. A robust management system should be in place to address changes, variations, and unexpected occurrences, ensuring reliable performance throughout the equipment's usage period.
This cleaning validation training consists of two distinct modules. The first day provides an overview, covering all aspects of cleaning validation. The second day delves into advanced topics, offering an in-depth exploration of specific issues crucial to understanding the current regulatory environment.
This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.
Benefits of attending
- Expand your knowledge on international cleaning validation guidelines
- Enhance your strategies for validation protocols
- Understand how to prepare the cleaning validation protocol and report
- Learn monitoring, revalidation, and validation maintenance for validated processes
- Master cleaning methods, cleaning mechanisms, cleaning agents, equipment grouping and risk-based decision making
- Clarify the logic of audit findings
- Get-to-grips with utilising a life cycle approach to cleaning validation
- Identify how to select sampling methods and sites, as well as proper selection of blanks and control
Who should attend?
Professionals responsible for various aspects of cleaning validation, including:
- Validation scientists
- Validation service personnel
- Production engineers
- Quality assurance specialists
- Quality control technicians
- Analytical chemists
- Regulatory affairs professionals
- Pharmacologists
- Toxicologists
- Technical support scientists
- Supervisors, managers, and directors of groups supporting cleaning validation
This course will cover:
Cleaning validation defined
- Regulatory guidance and expectation for cleaning validation
- ICH Q7, EU GMP Annex:1, Annex:15, PI 006-3:2007
- ISPE (International Society for Pharmaceutical Engineering), PDA (Parenteral Drug Association), ASTM (American Society for Testing and Materials) Guides
Definitions and documents needed
- Cleaning validation policy
- Cleaning validity master plan
- Cleaning validation protocol report
- Understandable cleaning validation SOP
- Design/development of a cleaning process
Calculations
- Principles and calculations of residue limits for a wide variety of residue types, routes of administration, and dosage types
- Non-uniform contamination
- Surface areas in carryover calculations
- Microbial criteria of cleaning validation
- Limits for "product X to product X"
- Biofilm formation and cleaning validation concerns
- DHT (dirty hold time), CHT (clean hold time) studies challenges
Analytical methods
- Selection of analytical methods, along with appropriate levels of analytical method validation
- Establish a soil library for a cleaning validation process
- Selection of sampling methods and sampling sites, selection of blanks and controls
- Selection of cleaning agents and cleaning mechanisms
- Robust recovery data
Health-based limits
- Rationale for health-based limits
- Biopharmaceutical cleaning validation approaches
- Establish permitted daily exposure (PDE)/ allowable daily exposure (ADE)
- Health-based approach to a possible chemical contamination
Critical process parameters and critical quality attributes
- Critical process parameters
- Critical quality attributes
- How to understand recovery studies
Group exercise - how to write a bulletproof cleaning validation protocol
- Critique of format
- Critique of content
Modes of cleaning
- Water quality for the state of the art cleaning validation
- CIP (Clean-in-Place) & COP (Clean-Out-of-Place) Concerns
- Approaches for indirect-product contact surfaces
- Approaches for non-product contact surfaces
- Manual cleaning validation difficulties
- Most difficult to clean areas on a surface
Life-cycle approach to cleaning validation
- Utilizing a life cycle approach for cleaning validation
- How to manage protein inactivation and degradation in Biotech Cleaning Validation
Risk assessment concerns
- Robust risk assesment to manage a successful cleaning program
- What is Spray covering testing?
Training
- Personnel training and qualification on cleaning validation
- Swabbing errors
- Visual cleaning and setting limits
Change control, revalidation, and continuous process verification
- Monitoring, change control, revalidation and validation maintenance for validated processes
- Using statistics in cleaning validation
Group exercise - how to perform a cleaning validation of a biopharmaceutical API (Active Pharmaceutical Ingredient)?
Cleaning validation for medical devices
- How to validate the cleaning of medical devices
Case studies
- Health authority inspection citations
- Which questions should be asked during an audit?
Bad practices
- Case studies and lessons learned from a cleaning validation bad practices
- Dangers during cleaning validation implementation
Mustafa Edik
Mustafa Edik is a leading pharmaceutical, biotechnoloy, medical device quality and GXP expert with over 28 years of hands-on leadership in GMP, GDP, GCP, GLP, and broader GxP compliance across the pharmaceutical, biotechnology, and medical device industries.
As Turkey's first IRCA-certificated Lead Auditor for GMP and Pharmaceutical Quality Management Systems (PQMS), he brings unmatched credibility and depth to audits, compliance strategies, and regulatory readiness. Holding a BSc in Chemistry, and a BSc (Hons) in Biopharmaceutical Sciences & Engineering from Atlantic Technological University (Ireland), and an Executive MBA, Mustafa combines strong scientific foundations with strategic business acumen.
His career highlights include senior roles at Bayer Türkiye, where he progressed from Quality Control Lab Supervisor to Deputy QA Manager, and GMP Lead Auditor to Global GMP Lead Auditor, managing complex quality operations and audits in a multinational environment. He has personally led more than 4,200 hours of GxP audits across over 200 facilities worldwide.
Today, as Founder and Lead Consultant at Quality Academia Eğitim & Danışmanlık, Mustafa delivers high-impact consulting, training, and project management services to local and global clients. His expertise spans across:
- GMP/GDP audits and supplier qualification
- Validation, qualification, and quality risk management (ICH Q9)
- Root cause analysis, CAPA, OOS/OOT, change control, and data integrity
- Sterile/non-sterile manufacturing, process improvement, and cost-of-quality optimisation
- Clinical trials (GCP & ICH E6), pharmacovigilance, and third-party manufacturing
- Regulatory alignment with FDA, EMA, PIC/S, MHRA, TGA, TMMDA, WHO, and ICH standards
Mustafa has trained over 9,000 professionals in GxP topics and designed certified auditor programs for Turkish authorities including Turkish MOH and Ministry of Agriculture and Foresty. He served as Principal GMP Consultant & Auditor at the Turkish Atomic Energy Authority, supporting successful TMMDA GMP approvals for 5 radiopharmaceutical products. As the first Turkish consultant selected by the Developing Countries Vaccine Manufacturers Network (DCVMN), he has led teams of 100+ engineers, auditors, and quality specialists while managing dozens of international projects.
A prolific author, Mustafa's works include:
- “Sorularla GMP Dokümantasyonu” – a practical guide to GMP documentation
- “GMP Audits in Pharmaceutical and Biotechnology Industries” (Taylor & Francis / CRC Press, June 2024) – a comprehensive reference on effective GMP auditing practices
Recognised internationally for his practical, risk-based approach and knowledge transfer focus, Mustafa Edik is dedicated to elevating pharmaceutical quality standards, helping companies achieve compliance excellence, reduce risks, and drive operational efficiency.
Ireland
- Alexion
- Xeolas Pharmaceutical Limited
- Zoetis
United Kingdom
- Argenta
- Immunocore Ltd
- MAC Clinical Research
Run Cleaning Validation - Best Practice in Pharmaceuticals Live online for your team
2 days
Typical duration
Pricing from:
- GBP 1,000
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our team to discuss your requirements:
