A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
5-6 Apr 2022 + 2 more dates
This intensive two-day course will introduce those who are new to medical device design and development to the critical elements of the process. It has been designed to provide delegates with an insight into the tools and techniques required to design and develop a medical device and offer an essential overview of the current regulatory landscape. The importance of safety and efficacy will be covered, as will risk management and documentation. As combination products are a huge market, the programme will also address device constituent parts of combination products.
Attending this event will provide delegates with a comprehensive appraisal of key aspects of this process and an opportunity to discuss the complexities involved with an experienced industry expert.Benefits of attending:
In 2003 David established PharmaDelivery Solutions Ltd as a specialised consultancy service in the field of drug delivery combination products (especially respiratory) device technology. This has led to involvement in projects with focus in pulmonary, nasal and other delivery routes, with an international client base. Much of the activity of PharmaDelivery Solutions Ltd is focused in the area of development programme support, regulatory GAP analysis and generation of documentation supporting development and test programmes, together with data review and contingency evaluation.
David has over 35 years experience in the development, industrialization and approval of inhalation drug delivery systems, combination products and medical devices.
PharmaDelivery Solutions Ltd has provided input ranging from GAP analysis and comment to complete remedial implementation in areas including
• Design Control
• Risk Management
• Materials strategies
• Regulatory documentation
• Technical reviews and opinion
In addition to activities supporting commercial organizations, David has been involved in the following roles;
Honorary Teaching Fellow in the School of Pharmacy and Pharmaceutical Sciences at the University of Manchester and is author/ tutor for the Pharmaceutical Industry Advanced Training (PIAT) MSc module on Inhalation dosage forms.
A UK national expert representing the British Standards Institute on ISO TC84 developing new international standards for pulmonary and nasal delivery devices syringes and catheters.
David has also worked with the United Nations and various national governments to develop and establish transition strategies from the use of CFC in Metered Dose Inhalers and to secure appropriate budgets from the Multi-lateral fun for the implementation of the Montreal Protocol in emerging markets around the world.
5-6 Apr 2022
09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 11638
Until 01 Mar
4-5 Jul 2022
London venue TBC
09:00-17:00 UK (London)
Course code 11844
Until 30 May
4-5 Oct 2022
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11727
Until 30 Aug
David was very knowledgeable about the course content, and was able to answer all questions put to him throughout the course. David did well to deliver the training via the webinar.
Oct 11 2021
Quality Engineer, Occuity
Oct 11 2021
All round excellent score. David was very clear with his diction and could not be faulted. He clearly has vast knowledge and experience in this field.
Junior Engineer, Osler Diagnostics
May 24 2021
Very good. A lot of information delivered clearly.
Design Development Director, Renfrew Group
May 24 2021
Eng manager, Renfrew group
Oct 14 2020
Good level of detail.
Head of New Concepts (S&A), TISSIUM
Nov 28 2019
I learned a lot and got some great insights into the process of design and development. It is an intense course with a lot of ground covered.
Reg Affairs, Ovelle Ltd
Nov 28 2019
Great overall. All topics of design control were covered well and I think everyone left with a better understanding than when they arrived. I have definitely applied some of the lessons we learned to my current role.
R&D Manager, Leica Biosystems
United States of America