||Sligo 5 days - June 4, 5, 6, & 11, 12
Limerick 5 days - June 18, 19, 20, 25, 26
Athlone 5 days - October 8, 9, 10 & 15, 16
||The programme is internationally approved by IRCA International Registration Scheme for certified training programme and Auditors.
|Number of Places
||Life Sciences Members 600 / person
||Fundamentals Of Quality, Drug GMP Requirements, Regulation, Auditing.
|Enrolment and Start Dates Comment
||Enrol by Friday 31 May 2013
Course starts Tuesday 4th June 2013 in Sligo.
Next course runs in Athlone 8 October 2013
||Lead Auditor Training IRCA Certified Course During the 5 days participants will acquire knowledge and skills in auditing. However, auditing like any other acquired skill requires practice. The best place to practice and extend your experience is during actual audits.
|Careers or Further Progression
||Professional Certified Lead Auditor
||Working with quality systems
Life Sciences Skillnet Administrator
Phone: 061 431802
||By the end of the course participants will be able to:
Describe the purpose of a quality management system and explain the 8 principles of quality management.
Explain the purpose, content and interrelationship of ISO 9000, ISO13485, ISO 9004 and ISO 19011.
Interpret requirements of ISO 13485 in the context of an audit.
Manage an audit programme.
Understand the different types of audits.
Describe the roles and responsibilities of auditors and lead auditors.
Plan and conduct an audit in accordance with ISO 19011, demonstrating ability to:
a) plan and prepare effectively
b) gather objective evidence, through effective interviewing,
observation, sampling and note taking.
c) analyse and interpret information in order to determine
conformance with requirements.
Report the audit, including writing valid, factual and value-adding non-conformity reports.
Undertake audit follow-up activities, including evaluating the effectiveness of corrective action.
Professionally liaise with external auditors.
|Methods of Assessment
||Theory and Practical
||Irish Quality Centre Galway & Sligo
Kelamc Group Clonmel
|Location of Course
||Sligo Radisson Blu