Training · Internal Auditor
Internal Auditor Training
One-day training for QA professionals and staff involved in self-inspection activities.
Introduction
Internal audits are a cornerstone of an effective Pharmaceutical Quality System. This one-day interactive course is designed for QA professionals, production or lab staff, and supporting functions involved in self-inspection activities.
What you'll learn
- The legal and regulatory framework: EU GMP Chapter 1, 21 CFR 211, ISO 9001, and 19011
- Setting up an annual audit plan and conducting a meaningful annual review
- The different types of internal audits (system, departmental, for-cause, SBIP)
- Planning and preparing audits: scope, checklists, previous findings
- Interview skills, audit note-taking, and asking the right questions
- Classifying and assessing observations
- Structuring a clear and objective audit report
- Managing audit follow-up and CAPA deadlines
Who is it for?
- QA staff involved in self-inspections or internal audits
- Production or QC staff selected as internal auditors
- Responsible Persons or QPs looking to strengthen their audit program