PPT Slide
AN INTENSIVE PRACTICAL TWO 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.
Bernard Tremaine is a Technical Specialist in FDA CFR 21 Regulations, YK2000 & 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
8.30am Registration and Coffee
9.00am - Welcome & Introduction
Speaker: Paul Shane Bennetts
- Overview of FDA CFR 21 Regulations
- Definitions & Classifications
- Controls General & Special
11.30 am - Overview of FDA CFR 21 Regulations Speaker: Bernard Tremaine
- Labelling
- Premarket Approval PMA
- Premarket Notification [510(k)]
- Investigational Device Exemptions (IDE)
1.30pm - Differences Between European & FDA Requirements
Speaker: Bernard Tremaine
- 21 CFR 800-1299 versus 93/42/EEC
- ISO 13485 versus EN 46000
- Other Differences
2.45pm - 510 (k) Submissions
Speaker: Bernard Tremaine
- Exemptions
- Who / When / Where to Submit ?
- What to Submit ?
- 510 (k) Review Process
- 510 (k) Handling Amendments / Supplements / Changes
4.45pm Questions & Assessment
Speakers Bernard Tremaine & Paul Shane Bennetts
5.00pm - Close of Training Day One
What others say about MDG’s training Courses -
‘MDG trained our staff in how to regulatory compliance with Global requirements for Medical & Drug Delivery Devices’
‘This training is simple & practical’
Staff Competence in FDA Compliance is a training requirement - a lack of training of your staff will rank as a non-compliance.
Right Approach: FDA surveillance is an on going process for retaining your Approval. You can’t afford to suffer a significant non-compliance at your FDA Audits & be classified as having Adulterated product
Right Profile : Correct Training of Your Staff will give you the correct compliance &peace of mind.
Right Result PRODUCT FOR SALE