The course goal is to provide you with the right skills to handle properly, the pharmaceutical CTD bioequivalence and biowaiver studies preparation & review. It covers all the areas of knowledge that a regulatory person needs to understand how to review, understand and assess the content of the mentioned studies. Eventually, having the capabilities to discuss, reply and fill forms related to regulatory authorities’ questions and procedures. Training is based on many reference guidelines such as ICH, US FDA, and many more. In the training, participants will work with practical examples and application, of the concepts presented. The course uses different ways of delivering knowledge like case studies, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable. You can find the course outline in the video above
The course goal is to provide you with the right skills to excel YOUR proper execution of cleaning validation in the food industry. It covers all the areas of knowledge that a person needs such as getting a basic understanding regarding the potential contaminants(soil types), in the food industry, and many more. The course uses different ways of delivering knowledge like case studies, videos, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable.
This course provides regulatory professionals with a practical review of Module 4 (Non-Clinical Study Reports) and Module 5 (Clinical Study Reports) of the Common Technical Document (CTD). Participants will learn how to interpret study data, assess compliance with international guidelines (ICH, FDA, EMA), and evaluate dossiers for accuracy and completeness, enabling more effective regulatory review and decision-making. The course uses different ways of delivering knowledge like case studies, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable. You can find the course outline in the video above
The course goal is to provide you with the right skills to understand Supplements and Cosmetic Registration. It covers all the areas of knowledge that a person needs such as knowing the requirements for importing and trading of special food, dietary supplements, sport nutrition products, and many more. The course uses different ways of delivering knowledge like case studies, videos, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable. You can find the course outline in the video above
The course goal is to provide you with the right skills to achieve better Deviation and CAPA Management. It covers all the areas of knowledge that a person needs such as how to have robust processes and procedures in place that deal with things that go wrong in pharmaceutical manufacturing and how to handle an unplanned event when it arises. The course uses different ways of delivering knowledge like case studies, videos, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable.
The course goal is to provide you with the right skills to understand Supplements and Cosmetic Registration. It covers all the areas of knowledge that a person needs such as knowing the requirements for importing and trading of special food, dietary supplements, sport nutrition products, and many more. The course uses different ways of delivering knowledge like case studies, videos, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable. You can find the course outline in the video above
The course goal is to provide you with the right skills to follow the right path in getting the CE mark for your products. It covers all the areas of knowledge that a person needs such as having a greater insight into the overall regulatory process of registering medical devices in Europe and obtaining a CE mark and many more. The course uses different ways of delivering knowledge like case studies, videos, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable.
The course European Cosmetics Regulatory Affairs – Product Information File (PIF) Training Course will equip participants with a clear understanding of EU Regulation (EC) No. 1223/2009 and the practical steps to achieve cosmetic product compliance. They will gain hands-on knowledge in preparing and maintaining a complete PIF and Cosmetic Product Safety Report (CPSR). The course enhances competence in managing labeling, claims, and CPNP notifications. It also empowers participants to effectively communicate with Responsible Persons, authorities, and auditors. Ultimately, it strengthens professional credibility and readiness to ensure market success within the EU cosmetic regulatory framework.
The course is designed to provide an overview of what is meant by data integrity, what needs to be considered during documentation completion, review, approval, and how to keep your data complete, consistent and accurate throughout the data lifecycle. The course uses different ways of delivering knowledge like case studies, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable.
The course goal is to provide you with the right skills of good storage and distribution practice for pharmaceutical and medical device products. It covers all the areas of knowledge that a person needs such as the importance of the quality and identity of pharmaceutical & medical device products during the whole distribution process and many more. The course uses different ways of delivering knowledge like case studies, videos, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable.
The course goal is to provide you with the right skills to understand Medical Device registration. It covers all the areas of knowledge that a person needs such as knowing the different requirements for registration & clearance of Medical devices in different Middle East countries such as Saudi, Jordan, UAE, and many more. The course uses different ways of delivering knowledge like case studies, videos, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable.
The course goal is to provide you with the right skills to handle properly pharmaceutical CTD files. It covers all the areas of knowledge that a person needs to be a successful regulatory personnel such as how to review & fill up module one of the CTD file based on ICH guidelines (ex. using JFDA & Gulf M1 forms) with practical application, and many more. The course uses different ways of delivering knowledge like case studies, videos, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable.
The course goal is to provide you with the right skills to handle properly pharmaceutical eCTD files. It covers all the areas of knowledge that a person needs to be successful dealing with eCTD software, its element, content, and standred requirements, and many more. The course uses different ways of delivering knowledge like case studies, videos, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable.
The course goal is to provide you with the right skills to excel in your pharmacovigilance work function. It covers all the areas of knowledge that a pharmacovigilance qualified person needs in his work such as how to make spontaneous reporting, how to prepare a good Individual Case Safety Report (ICSR), and many more. The course uses different ways of delivering knowledge like case studies, videos, group exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable.
The course goal is to provide you with the right skills to know the basic and latest information about the cGMP in the pharmaceutical, medical device and cosmetic industry. It covers all the areas of knowledge that a person needs such as the basic knowledge of what is GMP, what is Quality Management and the requirements for a quality assurance unit, and many more. The course uses different ways of delivering knowledge like case studies, videos, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable.
The course is designed to provide an overview of what is Site Master File (SMF) document. The SMF provides a comprehensive overview of a manufacturing facility and its operations. It’s essentially a detailed description of the premises, equipment, personnel, and quality management systems employed at a specific site. The course uses different ways of delivering knowledge like case studies, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable.
