This interactive seminar will provide a comprehensive overview of metered-dose inhaler technology. It will clarify the therapeutic targets and look at delivery technologies. Participants will gain a valuable insight into market potential and receive detailed information on the manufacturing process, quality and inspection requirements and the regulatory pathways to follow.
This seminar will be beneficial for those new to the area and those who require a refresher on the opportunities with this technology. The seminar format will include practical workshops and there will be plenty of opportunity for discussion with the trainer who has significant experience in this field.
The MDI – overview
The MDI – manufacturing process
The MDI – manufacturing equipment
The MDI – quality and inspection
The MDI – other performance
Challenges and opportunities for the MDI – development and technical
Challenges and opportunities for the MDI and DPI
Workshop (including coffee break)
Regulation of inhalation products
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.