GMP Lead Auditor

 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.