The FDA QSR Training module is a must for any organization that manufactures medical devices and is mandated to implement and comply with the Quality System Regulation 21 CFR Part 820. Every organization's management team should be at least knowledgeable of the requirements that pertain to their area of responsibility and authority.
The FDA QSR Training module is designed to provide participants with a knowledge and understanding of the Food and Drug Administration's Quality System Regulation (QSR). The module includes an introduction to Current Good Manufacturing Practice (CGMP) history and discusses some key terms cited in the regulation. The organizational benefits associated with implem:ntation and compliance with the regulation are also highlighted.
Additionally, the Quality System Inspection Technique (QSIT) used by FDA Inspectors during a facility in - spection is outlined and results from some facility inspections using this technique are trended to show common areas of non-compliance.
The module includes a detailed review of each of the QSR sections presented in simple, easy to understand language. An interrelationship diagram shows how each of the QSR sections are related.
Wherever the Regulation indicates that procedures need to be established, a procedure needs to be documented. Wherever the QSR indicates "where appropriate", the reqwrement is appropriate unless you can give justification to the contrary. The FDA QSR Overview module identifies where procedures are required and where documentation is appropriate.
The FDA QSR module also provides some guidance as to what to expect from Auditors and the types of questions that may arise during an inspection/audit.
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