Medical Device, auditing, medical devices
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Training : Quality System / GxP / GMP
GxP Quality Systems offer a range of training services to the Pharmaceutical and Medical Device Sectors
All training programmes can be customised to suit company requirements Courses are available at Induction, Foundation and Refresher levels and for all levels of responsibility. The competency of participants is assessed. Courses may be presented in-house or at external venues.
Our training services include:
- GMP / cGMP for Finished Pharmaceuticals – FDA & EU –Foundation level
- GxP for Managers & Technical Personnel- Advanced level
- GMP for the Laboratories QC & R&D
- Internal Auditor Training for GxP/ GMP/ Quality System Compliance
- QSR/ISO13485 for Medical Devices FDA & EU
- Clean Rooms and Aseptic Processing –EU Annex 1 & FDA
- Designing & Delivering Effective GxP /GMP Training
- Good Distribution Practices (GDP)
- Good Practices for Sales & Marketing
- GxP and the Role of the Marketing Authorization Holder (MAH)
Auditing : Quality Systems
- Internal GMP/cGMP audits of all your Quality Systems and/or train up your team of internal auditors.
- GxP audits of your raw materials, packaging suppliers, distributors, contract manufacturers or contract laboratories.
- Internal audits or supplier, contractor audits to EU MDD and ISO 13485 or FDA QSR
GxP Quality Systems have also acted as technical experts on third party registration audits to ISO9000. Our auditors are registered with the International Register of Certified Auditors (IRCA) and as part of that process must show evidence of a range of audits and of continuous professional development.
Consultancy: Quality Systems
- Development & Revision of GxP/ Quality Management Systems for Manufacturing, Laboratories, Storage & Distribution,
- MAH, Sales & Marketing
- Validation Master Planning, Protocol Development & Review of Reports
- Review of Documentation Systems
- Premises Layout & Finish Advice
- Company Cleaning & Housekeeping Programmes
- Microbiological testing systems
- Development of Company Training & Competency Programmes
- Design or Review of Internal Audit Programmes
- Site Master Files
In addition GxP Quality Systems can provide customized services to meet specific client demands.
, Gmp Auditing
, Medical Device
, medical devices