FDA QSR’s – Buildings Facilities
Information & Training. | Medical Devices
The FDA QSR regulations demand that facilities need to be appropriate to ensure quality operations can be performed, there needs to be suitable areas for the storage of equipment and materials. Manufacturing operations need to be performed in defined areas. Lighting will need to be suitable to the detail of the operations being performed. Environmental controls will be defined and controlled to maintain product integrity requirements. Raw materials will be received into defined locations and be quarantined or otherwise located per pre-defined procedures. Raw materials will remain quarantined until tested or confirmed as acceptable for use. Any non-conforming material will be rejected into clearly segregated areas. Drains will incorporate air-breaks. Waste and trash will be stored where necessary and disposed in a safe and sanitary manner. Suitable washing and toilet facilities will be available, appropriate to the expected peak staff and visitor numbers. Buildings will be maintained in a clean, sanitary state and in a good state of repair. There will be regular pre-defined cleaning schedules and appropriate cleaning agents shall be utilized Facilities will be rodent free with on-going rodent and pest elimination practices established.
FDA “QSR Buildings Facilities” Requirements.
Subpart G–Production and Process ControlsSec. 820.70 Production and process controls.
(f) Buildings. Buildings shall be of suitable design and contain sufficient space to perform necessary operations, prevent mix-ups, and assure orderly handling.
Information & Training.
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
- Information & Training presentation >>>