Implementation of ISO 13485 MasterClass
10 - 11 October, 2022
This MasterClass shall describe the general increase in combination products and in particular products now regulated by both drug and medical device regulation.
Implementation of ISO 13485 MasterClass shall describe the general increase in combination products and in particular products now regulated by both drug and medical device regulation it is important to decide if, when and how ISO13485 should be implemented within your organisation.
10 - 11 October, 2022, Virtual
Time Zone: UTC/GMT+1 /CET
This online training shall describe the general increase in combination products and in particular products now regulated by both drug and medical device regulation it is important to decide if, when and how ISO13485 should be implemented within your organisation. Examples include developing a design control process for a drug delivery device or ensuring the supplier of your metered dose inhaler applies the most appropriate manufacturing and quality plans. This could helps you to work out exactly when and how to implement ISO 13485 by considering different case studies and pharmaceutical company quality management systems.
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Who should attend?
• Combination product program managers
• Quality systems and compliance managers determining their compliance strategy for a drug-device combination
• DevelopmentEngineers andSupplyChainpersonnelinvolvedinDDCdevelopment or manufacture
"High attention to detail in course content and very well delivered"
Product Development Manager
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
USP PD Team Manager
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
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MT Sword Laboratories (BMS)
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