Process validation is the means of ensuring and providing documentary evidence that processes (within their specified design parameters) are capable of consistently producing a finished product of the required quality.
This course has been designed to focus on process validation for medical devices. Day one will review the Regulatory and Quality Management System (QMS) links to process validation - essentially the need for validation. It will look at the preparation steps to be taken, including initial Risk Assessment, User Requirement Specifications (URS), the format of URS and include a practical review of bad versus good examples.
Day two of the course reviews the Installation Qualification, Operation Qualification and Performance Qualification process (IQ, OQ and PQ) reviewing how this fits with regulatory needs and technical documentation. It will also look at the validation master plan and discuss continuous PQ and when that may be appropriate. Additionally, validation protocol content and execution, covering the recording of findings, managing excursions from required performance, plus other considerations will be reviewed.
Data integrity with an overview of the GAMPv (Good Automated Manufacturing Process) for software will also be included.
This is an excellent opportunity to receive a practical approach to Process Validation for Medical Devices.
Benefits of Attending
- Gain a clear understanding of how Process Validation fits into the Quality Management System
- Understand the regulatory drivers for Process Validation
- Know the scope of FDA, EU and UK guidelines
- Realise significant business benefits by clarifying the key purposes of validation
- Receive a practical demonstration of document format and content expectations
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
Course Provider
Mustafa Edik,
Independent GMP Consultant and AuditorAfter graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.
He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.
While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.
He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.
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
