One of the key focus points when auditing Active Pharmaceutical Ingredient (API) manufacturers is the responsibility to ensure patient safety. This course is designed to provide the assurance required to meet product safety and regulatory expectations.
Providing the skills to enable effective auditing and reporting on suppliers of APIs, this training considers the requirements of ICH Q7 and EU GMP Part II, as well as the expectations of regulatory bodies, both in the USA and Europe.
Interested in audit training for your team? Contact us today.
The course is suitable for those who have had some auditor training and experience in conducting audits. The training has been specifically designed for those responsible for assessing the content and findings of API audit reports as part of license applications and variations, as well as Qualified Persons responsible for the release of pharmaceutical products.
We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community