International pharmaceutical laws, regulations and guidance change at a frightening pace – it’s difficult to keep up! That’s why we have developed this one-day pharmaceutical legislation update “refresher” course for you. We keep track of all the changes, so you don’t have to. Just come along and learn what’s new and what’s on the horizon. Ideal CPD for the busy Qualified Person or pharmaceutical quality professional
About This Course
Pharmaceutical legislation and regulatory authority guidance is continually changing. These changes to legislation and guidelines, and the interpretation of them, can have significant implications for companies. Many changes require detailed planning to implement and failure to do so can result in serious compliance problems.
This is the continuation of a very successful series of one-day seminars that are designed to form part of your CPD.
This course is also Royal Society of Chemistry approved as suitable for their members’ CPD.
Key Learning Objectives
To understand and discuss the current interpretation of recently implemented and proposed changes to:
EU legislation: Directives and regulations
EU GMP: Chapters and annexes
The impacts of Brexit on biopharmaceutical processes and supply chains across the EU and the UK
ICH guidance
US legislation and FDA guidance
UK MHRA requirements and processes
Who Should Attend
Quality Assurance personnel, in particular Qualified Persons
Other technical/managerial personnel responsible for the manufacture and testing of APIs and medicinal products
Course Tutor
Peter Gough; Peter has over 40 years’ experience in the pharmaceutical industry and for the past 15 years has been responsible for advising senior management regarding changes to pharmaceutical legislation and guidance.
About This Course
Pharmaceutical legislation and regulatory authority guidance is continually changing. These changes to legislation and guidelines, and the interpretation of them, can have significant implications for companies. Many changes require detailed planning to implement and failure to do so can result in serious compliance problems.
This is the continuation of a very successful series of one-day seminars that are designed to form part of your CPD.
This course is also Royal Society of Chemistry approved as suitable for their members’ CPD.
Key Learning Objectives
To understand and discuss the current interpretation of recently implemented and proposed changes to:
EU legislation: Directives and regulations
EU GMP: Chapters and annexes
The impacts of Brexit on biopharmaceutical processes and supply chains across the EU and the UK
ICH guidance
US legislation and FDA guidance
UK MHRA requirements and processes
Who Should Attend
Quality Assurance personnel, in particular Qualified Persons
Other technical/managerial personnel responsible for the manufacture and testing of APIs and medicinal products
Course Tutor
Peter Gough; Peter has over 40 years’ experience in the pharmaceutical industry and for the past 15 years has been responsible for advising senior management regarding changes to pharmaceutical legislation and guidance.
