QMS Lead Auditor for the pharmaceutical supply chain (PS9000/ISO9001) – IRCA PR330

This 5 day fully residential course, provides the most comprehensive certification for Lead Auditors to the supply chain in the Pharmaceutical industry. Fully accredited by IRCA and PQG, this is a highly customised Lead Auditor training course that provides the delegate with a qualification in auditing that is recognised by the International Register of Certified Auditors(IRCA) to ISO9001 Quality Management Systems and The Pharmaceutical Quality Group (PQG) PS9000 Pharmaceutical Supplier Standards. PLEASE NOTE - unlike some other training providers, we include all your hotel accommodation, breakfast and meals, in the price.

This course is founded on the audit principles defined in ISO19011:2018, and supporting ISO standards, and provides an excellent structure on which to introduce, develop or monitor both internal and external audit processes. PR330 incorporates the principles of performing 1st, 2nd and 3rd party audits as a Lead Auditor to the supply chain of pharmaceutical manufacture. This course is intended for individuals to acquire the knowledge and skills to lead audits of suppliers utilising ISO9001, PS9000, ISO9001, EXCiPACT, ISO15378, and IPEC. The regulatory background for medicinal products and an overview of the standard content is discussed. Exercises are also included for ICHQ7 for active pharmaceutical ingredients however this does not form part of the examination process detailed below.

PLEASE NOTE to comply with the IRCA certification rules, we are required to conduct an interview, prior to the course. It is just to check your background and past auditing experience etc. There is also a significant amount of course pre-work.

Knowledge of  ISO9001, ISO15378, PS9000, IPEC and EXCiPACT standards is desirable prior to the course, however, just in case you are new to them, we have designed pre-course work to help you.  During the course, our tutors will take you through each stage of the audit process, and provide you with experience of applying different standards in an audit situation, with a final full audit process using ISO9001.

It is also desirable you have some knowledge in the following areas: Quality Management systems and the core elements of a management system and the interrelationship between top management responsibility, policy, objectives,planning, implementation, measurement, review and continuous improvement, The quality management principles (see ISO 9000) are also desirable and the relationship between quality management and customer satisfaction and also ISO9001.

• Day 1
• Accreditation structure and auditor competence
• Types of audits
• Quality concepts and audit relationships
• Establishing an audit programme
• Risk analysis
• Conducting an audit
• Day 2
• Internal audits
• Why audit and audit frequency
• What’s so special about pharmaceuticals?
• Construction of non-conformities
• Nonconformity critique/ reporting
• Guidelines for Suppliers to the pharmaceutical industry
• The different standards
• Change control and supplier management
• Review of PQG pharmaceutical specimen exam paper
• The paper audit
• Day 3
• PQG pharmaceutical exam
• Roles and responsibilities
• Conducting opening meetings
• Personal attributes and active listening
• Questioning techniques
• Communication during meetings
• Conducting closing meeting
• Audit role play
• Day 4
• Audit role play including, opening meeting, conducting the audit, preparation for closing meeting and closing meeting
• Effective communication
• Categorising audit findings and completing audit reports
• Maintaining and reviewing an audit programme
• Preparation for the IRCA lead auditor exam
• Review of IRCA paper - selected questions
• Day 5
• Definition revision
• Non conformity reports
• Review of IRCA specimen examination paper
• Review of ISO 9001 standard
• Review of ISO standards
• IRCA lead auditor exam