Quality System Regulations (QSR) for Medical Devices CGMP 21 CFR Part 820
This introduction carefully examines the requirements of the QSR and product safety in order to prepare companies for the design requirements.
- The FDA requirements and how they might affect an organisation.
- Implementing the requirements effectively so as not to affect other regulatory requirements.
- Locating key pieces of information within the appropriate documents (DHF, DMR and DHR).
- Review of related standards such as risk analysis and the applicable guidance documents.
- The relationship between QSR and the MDD/IVDD and ISO13485/ISO9001 requirements.
- The regulatory requirements for reporting incident/near incidents (MDR).
- Addressing 21 CFR Part 11 Electronic Signature and Records.
- Adding value to an organisation’s management system.
- Preparing for an FDA QSIT type audit.
- Sources of information and further development
- Executives and Senior Management
- R&D Managers/Engineers and Members of Design Review Teams
- RA/QA Managers and Management Representatives
- Members of multi-discipline Design Teams
- Sales and Marketing, Production, Shipping, MIS, Purchasing
- Interpret the requirements of QSR and its relationship with MDD/IVDD and ISO 13485/ISO 9001 requirements.
- Identify the methods for successful implementation of the Regulations
- Prepare for an FDA QSIT-type audit and add value to an organisation’s management system.