Richard Young's core skills can be broadly divided into 4 main areas Regulatory Affairs, GMP (Quality Assurance), GLP (Laboratory Testing) and GCP (Clinical).
These core skill areas have been developed over 2 decades of experience with products ranging from class 3 devices such as Orthopaedic implants (IIb) neurological robots, through electromedical devices such as infusion systems and cardio vascular products. Richard brings a blend of pragmatism and experience to these disciplines that facilitates insightful problem solving approaches as well as solid solutions.
Richard has also had broad experience in a wide range of materials and manufacturing technologies including sterilisation, plastic moulding, software development, electronic medical devices, ceramics, CNC machining, plasma coatings, packaging, extrusion and automated assembly. QUALIFICATIONS & CORE TRAINING. IEC 60601 Electrical Safety, University of Liverpool. Software Validation. Project Management. B600 Foundations for Senior Managers Stage 1 MBA (Open University). Lead Assessor ISO13485/ISO9001 for Medical Devices, GMP, GLP.
This 1-hour webinar is intended to introduce auditors to the techniques appropriate to conducting a project audit