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Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation
ComplianceOnline
|
Short University Courses
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Online
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Self-Paced Online
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. This new...
Regulatory and Related Activities Through the Lifecycle
The Organisation for Professionals in Regulatory Affairs
|
Professional Training
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From 1,700 GBP
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Multiple (2)
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Classroom, Self-Paced Online
This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of a variety of topics of...
Quality Management Systems Lead Auditor Training, Incorporating ISO 13485:2016 and MDSAP Requirements (CQI/IRCA Certified)
NSF International, Health Sciences
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Professional Training
5.0
(3)
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Intermediate level
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From 3,000 USD
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Online
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Virtual Classroom
This course provides you with the skills and knowledge that have taken many experienced auditors decades to develop. During the...
European In Vitro Diagnostic Regulation (EU IVDR) Internal Auditor course
NSF International, Health Sciences
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Professional Training
5.0
(4)
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Intermediate level
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From 1,500 USD
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Online
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Virtual Classroom
This instructor-led two-day course provides practical instruction for auditors undertaking internal and supplier audits for the European In Vitro Diagnostic...
QA QC GXP for Pharmaceutical Production
University of Copenhagen - Faculty of Health and Medical Sciences
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Short University Courses
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Copenhagen
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Classroom
This course is for you having an academic background with little or no knowledge of the different stages of the...
Regulatory Control of Clinical Operations
The Organisation for Professionals in Regulatory Affairs
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Professional Training
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From 1,700 GBP
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Multiple (2)
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Classroom, Self-Paced Online
Lectures and workshops will cover the understanding and application of modern approaches and understanding of regulatory requirements for carrying out...
Regulatory Strategy for a New Active Substance: Global Clinical Development
The Organisation for Professionals in Regulatory Affairs
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Professional Training
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From 1,700 GBP
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Online
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Self-Paced Online
This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of global clinical...
The EU Regulatory Environment - Procedures and Applications
University of Copenhagen - Faculty of Health and Medical Sciences
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Short University Courses
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Copenhagen
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Classroom
This course addresses the current and practical aspects of getting medicines approved in the EU. After completion the student will...
Regulatory and Compliance Requirements for CMC Analytical Studies
PTI
|
Professional Training
5.0
(1)
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From 880 GBP
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Online
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Self-Paced Online
The course will provide you with regulatory and compliance clarity to ensure your analytical practices meet global requirements. Over 4...
Self-Inspections – How to Make Them Add Value to Your Organisation
NSF International, Health Sciences
|
Professional Training
5.0
(2)
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From 95 GBP
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Online
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Self-Paced Online
Why do you conduct self-inspections and why are they important to your organisation? This E-Learning session provides an overview of...
The US Regulatory Environment
University of Copenhagen - Faculty of Health and Medical Sciences
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Short University Courses
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Copenhagen
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Classroom
The course provides an in-depth overview of the US FDA organization, history, legal standing and roles and responsibilities in the...
Quality Improvement Science and Systems Analysis
University of Oxford
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Short University Courses
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This course results in CPD hours
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Oxford
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Classroom
The Quality Improvement Science and Systems Analysis course introduces the principles and core methodology of industrial quality improvement methods with...
Supervisory Skills for Technical Services
University of Leeds - Faculty of Engineering and Physical Sciences
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Professional Training
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This course results in CPD hours
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Leeds
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Classroom
Good supervision of aseptic processing is essential for ensuring a high quality, efficient and safe service. As the quality of...
Comparability for Biologics
PTI
|
Professional Training
5.0
(9)
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From 1,595 GBP
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Vienna
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Classroom
The quality, safety, efficacy and regulatory approval of your biopharmaceuticals is strongly connected to the process changes during the manufacture...
Equipment, Facilities and Utilities Qualification - Bitesize Course
NSF International, Health Sciences
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Professional Training
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From 195 GBP
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Online
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Virtual Classroom
Pharmaceutical validation has been a regulatory requirement for nearly 40 years and continues to attract significant regulatory attention. As well...
Genotoxic Impurities - Strategies for identification and Control - Online Academy
PTI
|
Professional Training
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From 700 GBP
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Online
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Self-Paced Online
Through this four week course participants will gain a crucial understanding of the control of genotoxic impurities (GTIs) in relation...
GxP Inspection Management Lifecycle
NSF International, Health Sciences
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Professional Training
5.0
(3)
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From 95 GBP
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Online
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Self-Paced Online
This training course covers the GxP Inspection Management Lifecycle. It is suitable for staff wanting to understand more about GCP,...
Preparing the Quality Module of the CTD
PTI
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Professional Training
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From 1,100 GBP
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Online
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Self-Paced Online
The Quality and Pharmaceutical Module (Module 3) of the Common Technical Document (CTD) is arguably the most challenging aspect of...
Quality by Design (QbD) in Pharmaceutical Development
University of Copenhagen - Faculty of Health and Medical Sciences
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Short University Courses
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Copenhagen
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Classroom
Quality by Design lies at the very heart of modern pharmaceutical development. The implementation of QbD principles provides a cost-effective...
Understanding and Preparing the Quality and Pharmaceutical Module of the Global CTD Dossier
PTI
|
Professional Training
5.0
(1)
-
This course results in CPD hours
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From 1,995 GBP
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London
-
Classroom
This comprehensive three-day course will provide delegates with a clear understanding of the US and European regulatory requirements for Module...
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