This In-house course provides a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products. It is ideal for newcomers and a good refresher for those with more experience.
This In-house course provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.
This one day In-house course has been designed to enable delegates to understand the science behind capsule-based inhalers.
This In-house course provides practical guidance on borderline issues and combination products
This in-house provides a unique opportunity to meet Competent Authorities, Notified Bodies, Lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to Post Marketing Surveillanc including Vigilance
This In-house course will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the ‘general controls’ applicable to all devices.
This one-day In-house course has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device
In this In-house course compare different requirements of ISO 13485.
A comprehensive In-house course of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.
In this In-house course gain a practical advice on how regulations are being applied to enable you to maximise on this rapidly growing market.
In this In-house course, gain practical advice on how regulations are being applied to enable you to maximise on this rapidly growing market.
This In-house course will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East.
This In-house course provides an Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management
This In-house course has been designed specifically for those who are involved in gathering clinical evidence required for medical devices and in-vitro diagnostic products.
This In-house course gives an essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting.
This In-house course manages the transition to the new regulation.
In this In-house course be guided through topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.