PPT Slide
AN INTENSIVE PRACTICAL ONE DAY COURSE
Paul Shane Bennetts is the Managing Director of M.Devices Group. He has previously worked Pharmaceuticals and more recently with Medical Devices & Drug Delivery Devices. An auditor in Quality & Regulatory Systems for Europe & the USA.
Benard Tremaine is a Technical Specialist in 93/42/EEC general Strategies, IRCA registered Lead Auditor (A007435) & an Active Medical Devices Specialist, covering:Electrical Safety, Vital Signs Monitoring. Life Support Equipment, Catheterisation, Laboratory Catheterisation, Quality Assurance, Regulatory Assurance, Stress Test Systems
9.15am Registration and Coffee
9.30am - Compliance Requirements of the MDD
Speaker: Paul Shane Bennetts
- Auditing within a regulatory system
- Intended Use & Conformity Routes
- Compliance requirements of the MDD
- Application of Standards
- Key issues associated with the MDD
- invoked compliance
10.15 am - Technical Documentation & Essential Requirements
Speaker: Bernard Tremaine
- Understanding the DMR & the DHF
- Technical Documentation Requirements
- How to assess the Essential Requirements
- How the Notified Body performs an Assessment
11.30 am - Auditing Schedule Planning & Assessment
Speaker: Bernard Tremaine
- Planning the Audit Schedule
- Understanding the relevance of Feedback & Corrective Action
- Preparing for the first Audit Assessment
2.00pm - Practical Auditing Session
Lead Auditor: Bernard Tremaine
- Auditing to the Audit Schedule
- Assessment against the System, the Documentation & Activities
- Recording
- Assessing the level of non-compliances
3.15pm - Practical Auditing Session Continued
Lead Auditor: Bernard Tremaine
- Internal Auditors Assessments
- Agreeing Corrective Action with the responsible person
- Writing the Audit Report
- Scheduling the follow up & close.out
4.15pm Questions & Assessment
Auditors Bernard Tremaine & Paul Shane Bennetts
- Award of Training Certificates
5.00pm - Close of Training Day
What others say about MDG’s training Courses -
‘MDG trained our staff in how to achieve auditing compliance with the Medical Devices Directive’
‘This training is worth much more than the cost’
Staff Competence in CE Auditing Compliance is a training requirement - a lack of training of your auditing staff can rank as a non-compliance.
Right Approach: Notified Body surveillance is an on going process for retaining your CE mark. You can’t afford to suffer a significant non-compliance at your CE Audits.
Right Profile : Correct Training of Internal Auditors will give you the correct compliance & peace of mind.
Right Result YOUR CE MARK