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.
CPD Hours: 12
Course Content
- Day 1
- Cleaning validation defined
- Definitions and documents needed
- Calculations
- Analytical methods
- Health-based limits
- Critical process parameters and critical quality attributes
- Group exercise - how to write a bulletproof cleaning validation protocol
- Modes of cleaning
- Day 2
- Life-cycle approach to cleaning validation
- Risk assessment concerns
- Training
- Change control, revalidation, and continuous process verification
- Group exercise - how to perform a cleaning validation of a biopharmaceutical API (Active Pharmaceutical Ingredient)?
- Cleaning validation for medical devices
- Case studies
- Bad practices
Speakers
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.
