Do you audit your GMP environment, either self-inspections or outsourced providers? Are you armed with the tools required to carry out audits to the latest guidelines? This course provides the essential skills to plan and conduct audits with improved ability and confidence, ensuring you know how to correctly assess conformance to the correct GMP and ICH Quality guidelines.
Fully
accredited by IRCA, our GMP PQS Lead Auditor (PR325) course covers the whole
audit cycle, from setting the annual audit programme, through to planning,
conducting, reporting and follow-up of audits to cGMPs, ICHQ10, API and
excipient standards and guidelines. Delegates will be assessed through
practical tasks, using real world case studies and mock audits covering
internal audits and self-inspections, external outsourced GMP Audit Training and a range of dosage forms.
We are proud
to have trained hundreds of auditors from all over the world. With a pass rate
of over 90% (IRCA average is his 76%), our tutors are top examiners in their
fields and are passionate about passing on their skills to the next generation
of examiners.
Our Lead Auditor course is IRCA accredited, flexible and tailored to industry needs. We offer a range of delivery options, including face-to-face (at home), online with teacher-led blended learning and in-house with bespoke programs for the whole team. To ensure the quality and attention you expect from our training, the number of participants on our courses is limited to 12 people.
What does the course fee Include?
Course and
supporting materials (available in digital or printed format)
Certificate
of course participation
Accommodation
and all meals (this applies to RSSL only)
Full access
to expert instructor support during the course
Exam fee
This course
covers auditing GMP quality systems for pharmaceutical products including
ICHQ10 It is aimed at individuals who want to acquire the knowledge and skills
to This allows you to conduct effective internal audit and external
self-management audit programs that significantly contribute to your GMP
security obligations. The participant must have sufficient knowledge about her
GMP and ideally she will have 3-5 years' experience in a GMP environment before
taking the course.
RSSL takes
pride in providing a safe and nurturing learning environment for all
participants. We are also specially trained to provide effective learning
environments for neurodiverse people.
Course Requirements
In order to
comply with IRCA accreditation rules, your instructor will conduct a short
interview before taking your course. This will help you understand the level of
participation expected during the course, readings, course preparation, and
discuss your personal learning goals so we can meet your needs.
