Dr Holger Kost, Kettenbach GmbH & Co. KG, Eschenburg, Germany
The medical device industry is a strongly regulated business. Depending on the classification of the device, supervision from a Notified Body and partially from an authority is required. From the development of a medical device until the daily production and quality control, a lot of data come up, which can can be either generated manually or electronically. Besides, the data must be generated, handled and archived in such a way that the auditor/inspector has no objections to it. To assure this, the data management life cycle starts with the generation of data and ends with archiving or destructing. In the field of medical devices, only a few requirements from guidelines are available. There is an exception, though: the export of medical devices to the USA. In the USA, the compliance with 21 CFR 11 regarding the handling of electronic data is mandatory. Now, what can give some orientation for the EU market? What requirements are mentioned in ISO 13485? Could GMP rules for medicinal products/drugs also give hints for medical devices? All these questions and other items with focus on medical devices will be discussed during this webinar.
This webinar adresses employees who are responsible for data governance, e.g. (developers, QM, Regulatory Affairs, production, quality control etc.) in companies which develop, manufacture, and controls medical devices. Consultants for the Medical Device Industry are also addressed.
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The following topics will be covered:
- Overview of Regulations: from ISO 13485 to 21 CFR 11
- What are Quality-Related Data?
- Primary data, raw data, metadata, QC / QA data, Manufacturing data
- Static and dynamic data,Classification of data
- Data integrity - Criteria and Principles
- ALCOA and ALCOA+ criteria
- Data Life Cycle Management, Data management and controls
- Validation of computerised systems regarding data integrity
- How to secure data integrity at and from a service provider
- GITP – Good IT Practice, what does this mean in terms of Data Integrity?
- Paper vs. electronic data
- User management – what is state of the art
- Working with Excel sheets
- Data protection and recovery, Disaster recovery
- Audit Trail, Audit Trail Review
- Change management
- Cloud computing and data integrity – a real challenge