About this course
In a recent review of FDA warning letters, EU Notified body assessments and the specific introduction of combination product regulations it is clear that the concepts and techniques used in design control and risk management are still unclear to manufacturers wishing to implement, improve and maintain their development processes.
In order to address this we have established a programme specifically aimed towards not only introducing the requirements but enabling you to implement best practices for combination product types including Drug Delivery devices such as Metered Dose Inhalers and Auto-injectors.
A medical device manufacturer must demonstrate safety and function of its product through formal test and evaluation methods. This course outlines the regulatory requirements for product validation and introduces the formal expectations from regulatory agencies relating to the validation of a product. Focussing upon the development of Harmonised standards and product specific standards this course will provide a significant overview of how to address the critical product verification and validation requirements for regulatory submission.
Course outline
- Review and implement the fundamentals of Product Validation and Performance evaluation within a medical device organisation
- Evaluate how medical device product specific standards are developed and subsequently adopted by regulatory agencies
- Apply the logic required to systematically demonstrate a product has been appropriately validated for its function
- Determine the procedures required by an organisation to ensure that company developed test methods are based upon robust science, engineering and quality assurance principles.
Venue
Manchester Marriott Victoria and Albert Hotel, Manchester, UK
The Manchester Marriott Victoria & Albert Hotel stands on the banks of the River Irwell, near the city centre but convenient for Manchester Airport (19km), the city’s Piccadilly rail station (3km) and the UK’s motorway networks.
Recently lovingly restored, this Grade II listed building bears many modern features. The hotel has its own car park and a few minutes’ walk takes you to the city’s main shopping and eating district.
Hotel Accommodation
- Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Venue Address and Contact Details
Manchester Marriott Victoria & Albert Hotel
Water Street
Manchester
M3 4JQ
England
Tel: +44 (0) 161 832 1188
Fax: +44 (0) 161 834 2484
www.marriott.co.uk
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our expert for this course is James Pink.
What you've said
This a new course for 2014
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