Data integrity has received more attention than ever before in the last decade and has become the most critical audit topic for health authorities. Although data integrity has started to gain importance in recent years, its history dates back approximately 30 years. Data integrity breaches at Barr Laboratories and later Able reveal this issue is older than it seems. As the health authorities began to question data integrity in audits more and more, pharmaceutical manufacturers started to increase their focus on data integrity, especially in GMP audits, and they started to seek ways to train their internal audit teams with this in mind. This approach acts to detect the deficiencies and deviations that will be found in internal audits prior to the health authority audits.
Although there are numerous data integrity training courses available, the training rarely discusses the audits in detail, which leaves companies trying to solve their problems with a little guesswork based on their own knowledge and experience.
In this course, the concept of data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed. The programme will also advise in which departments data integrity audits should be carried out. Data integrity audits of the; warehouse, production, quality control, quality assurance, critical utilities, and engineering departments in pharmaceutical production facilities will be covered, with sample applications and question lists, and the most critical audit findings encountered in health authority audits will be examined. During this two-day training programme, the participants will analyse case studies and scenarios, which will aid the learning process.
Benefits of attending
- Learn the requirements of data integrity audits and health authority expectations
- Evaluate the concept of data integrity from a completely different perspective
- Understand the requirements of the role and necessary skills of the data integrity auditor
- Explore how to audit and prepare for external data integrity audits in the following departments; warehouse, manufacturing, quality control, quality assurance, critical utilities, and engineering
At the end of the course, there will be a short assessment exam with case studies and audit scenarios which will be analysed during the course, and those delegates who are successful in the assessment exam will receive the title of ‘Certified Data Integrity Auditor’.
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Speakers
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
Personnel from the following departments will benefit from this course:
- Quality assurance and quality control
- Validation
- R&D
- Audit
- Regulatory
- IT
- Warehouse and supply chain
- Engineering
- Procurement
As well as:
- Health authority inspectors
