This course highlights the proposed and recently implemented changes to UK law and regulatory guidance that will impact the manufacture and distribution of medicinal products, across the product lifecycle, and will provide valuable insights for personnel, in quality, regulatory, management or technical support roles in the pharmaceutical industry.  It will help Qualified Persons to fulfil their legal obligation for continuing professional development (CPD). PLEASE NOTE: As well as being available to purchase individually these Pharmaceutical Legislation and Guidance eLearning updates are also available to purchase together as an annual subscription service.  The advantages of the subscription are as follows: All four courses (EU, UK, USA and International) are provided for less than the cost of 3 individual courses The full recordings, updated each quarter year, on the LMS are available on the LMS throughout the whole of the year of your subscription A shorter summary of what has changed in the past quarter, across all four regions, is provided with each quarterly update Each quarter you will be invited to a live, Zoom Q&A session 2 to 3 weeks after the publication of the quarterly update To enrol in the subscription service, click here. Read more

This course highlights the proposed and recently implemented changes to guidance issued by US organisations that will impact the manufacture and distribution of drug products, across the product lifecycle, and will provide valuable insights for personnel, in quality, regulatory, management or technical support roles in the pharmaceutical industry.  It will help Qualified Persons to fulfil their legal obligation for continuing professional development (CPD) if they are certifying products for the US market. PLEASE NOTE: As well as being available to purchase individually these Pharmaceutical Legislation and Guidance eLearning updates are also available to purchase together as an annual subscription service.  The advantages of the subscription are as follows: All four courses (EU, UK, USA and International) are provided for less than the cost of 3 individual courses The full recordings, updated each quarter year, on the LMS are available on the LMS throughout the whole of the year of your subscription A shorter summary of what has changed in the past quarter, across all four regions, is provided with each quarterly update Each quarter you will be invited to a live, Zoom Q&A session 2 to 3 weeks after the publication of the quarterly update To enrol in the subscription service, click here. Read more

This course of four chapters will give you a sound basis of the regulatory requirements expected of a good pharmaceutical cleaning process, how to calculate limits and their justification. The pros and cons of various cleaning methods and how to approach them. Finally, how to plan and approach a validation exercise with specific cleaning acceptance criteria. Read more

This course provides an overview of the US and EU regulatory framework relative to combination products.  This course will discuss the primary mode of action (PMOA), key stakeholders, and Drug-Device Combination (DDC) product requirements as well as a brief discussion of the regulatory framework for jurisdictions beyond the US and EU. This course is approximately 1.5 hours in length and includes knowledge checks after each topic and a competency assessment.  Read more

The purpose of this course is to provide an overview of current good CSV practice along with some practical advice about how to achieve good outcomes in a cost-effective and resource-efficient way. Read more

Course 1 of our Data Integrity Series Problems with data integrity continue to lead to vigorous regulatory actions. Such issues can be prevented with a thorough knowledge and understanding of the regulators’ requirements.  This eLearning course is aimed at anyone working in the Pharmaceutical Industry and is designed to provide an overview of what is meant by data integrity, what needs to be considered during documentation completion, review and approval and how to keep your data complete, consistent and accurate throughout the data lifecycle. This course is course 1 of our Data Integrity series.   Read more

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