The purpose of this course is to provide candidates with some practical tools for validation - including qualification, process validation and analytical method validation. Validation is a regulatory requirement of the international pharmaceutical industry, but the process of doing it can become bureaucratic, complicated and lack clarity as to what is important. The intention of this training is to provide information, tools and processes to make validation understandable and therefore enable participants to apply the learning back at their company.
The course will include presentations, exercises and case studies, including content from RSSL’s own analytical lab experiences.
Please note: The course content does not cover cleaning validation or computer systems validation, but these topics are covered in our Pharmaceutical Cleaning Validation and GxP Computerised Systems Validation and Compliance courses.
This course is suitable for people in pharmaceutical development, manufacturing and quality, plus support functions such as engineering or validation. It is applicable to a wide range of people e.g. from those working in companies producing novel medicines to those producing generics; or from large multi-national to ‘virtual’ companies.
The course covers facility qualification, process validation and development and validation of analytical methods. It covers approaches in Europe, US and International, including ICH requirements and the regulatory authority guidance.
£1390 (+VAT)
The course will include presentations, exercises and case studies, including content from RSSL’s own analytical lab experiences.
Please note: The course content does not cover cleaning validation or computer systems validation, but these topics are covered in our Pharmaceutical Cleaning Validation and GxP Computerised Systems Validation and Compliance courses.
This course is suitable for people in pharmaceutical development, manufacturing and quality, plus support functions such as engineering or validation. It is applicable to a wide range of people e.g. from those working in companies producing novel medicines to those producing generics; or from large multi-national to ‘virtual’ companies.
The course covers facility qualification, process validation and development and validation of analytical methods. It covers approaches in Europe, US and International, including ICH requirements and the regulatory authority guidance.
£1390 (+VAT)
