This event is cancelled or expired.
May
2017
Pharmaceutical GMP Audits and Self-Inspections
United Kingdom, Manchester
Course Overview :
An IRCA Certified Pharmaceutical QMS Auditor/Lead Auditor Course - Learn how to perform your best audit ever! And, have the opportunity to become a Certified Pharmaceutical QMS Auditor! This intensive 5 day course, taught by highly experienced pharmaceutical auditors and former regulatory agency inspectors, will provide you with the knowledge, understanding, skills and confidence to audit all aspects of pharmaceutical manufacture and control, whilst retaining the cooperation and respect of the auditees.
About This Course :
An IRCA Certified Pharmaceutical QMS Auditor/Lead Auditor Training Course No. A17638
Since its design, launch and certification in late 2011, this Pharmaceutical Quality Management System Lead Auditor course has trained over 200 delegates per year. The course has had fantastic delegate feedback.
This highly interactive course takes the form of a mock or virtual audit. It assumes experience and working knowledge of GMP guidelines in the region the auditor is working (EudraLex Volume 4 or US CFR 21), or previous attendance at an NSF Pharmaceutical GMP course.
- The course follows ISO 19011 guidelines for quality and management systems auditing
- The course is prepared using pharmaceutical industry standards including:
- GMP
- ICH Q8, 9, 10
- PS 9000
- ISO 9000
With special emphasis on the Quality Management System
Benefits and Key Learning Objectives:
We all face increasing pressure to audit more with less, this course provides…
- A toolkit of auditing skills designed by pharmaceutical auditing experts for Pharmaceutical Quality Management System Auditors covering:
- How to develop into an even better auditor
- How to structure, plan and manage your audits
- How to develop your technical and non-technical skills
- How to perform your best audit ever
- Expert advice/experience and clinics for your auditing concerns
- The GMP context for Pharmaceutical Quality Management System Lead Auditors
- Tutors with credibility; they include former very highly regarded inspectors and Pharmaceutical Lead Auditors with a wealth of experience
- Superb success rate for students
- Unparalleled support and reference material for delegates
- Personal assigned tutor to maximize your learning experience and exam opportunity
- Essential guidance for auditors of suppliers, contractors, CMO, service providers, outsourced activities and self-inspectors
- Essential education and development for QPs, those auditing on behalf of QPs and external and internal auditors wishing to improve
- Essential training for those who need to demonstrate suitable experience and training to inspectors
- Techniques for those who could face audits
- An essential knowledge base for anyone wishing to improve Pharmaceutical Quality System audits
Certifications :
This course meets the training requirements for the new IRCA (www.irca.org) Certification of Pharmaceutical Quality Management Systems Auditor/ Lead Auditor (PQMS).