Overview
Gain the knowledge and practical expertise required to successfully implement process validation within the medical device industry. This comprehensive training provides a thorough understanding of regulatory expectations, validation methodologies, and industry best practices, while equipping participants with the practical skills to plan, execute, document, maintain, and continuously improve process validation activities throughout the product lifecycle.
Through interactive workshops, real-world case studies, and scenario-based exercises, participants will gain hands-on experience in applying key validation principles, including risk assessment, User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), validation planning and documentation, data integrity, and software validation considerations. The course also explores Validation Master Plans, continuous process verification, and managing deviations during validation execution.
By bridging regulatory requirements with practical implementation, this training enables participants to confidently apply process validation principles, enhance product quality, ensure regulatory compliance, and support the delivery of safe and effective medical devices.
CPD Hours: 12
Course Content
- Day 1
- Why is Process Validaton Needed?
- Where to Start?
- User Requirement Specification (URS)
- Group Exercise - Review of an Existing URS
- Workshop: URS
- Day 2
- Factory Acceptance Test
- Site Acceptance Test
- Facility Qualification
- Computerized System Validation
- Cleaning Validation
- Personnel Qualification
- Analytical Method Validation
- Supplier Assessment
- Instalation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
- Validation Protocols
- Valdiation Protocol Execution
- Change Control, Revalidation & Requalification
- Group Exercise: Review of Exisiting Validation Plan & Report
- Workshop: Validation Plan & Report
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.
Who Should Attend
Who Should Attend
- Validation specialists new to the medical device industry
- Quality and Regulatory specialists wanting to understand where Process Validation fits into compliance needs
- Process engineers
- Validation and Qualification managers
- Operations managers
