Audit

Lead Auditor Training - IRCA Certified

Network: 
Life Sciences Skillnet
Duration 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
Comment The programme is internationally approved by IRCA – International Registration Scheme for certified training programme and Auditors.
Number of Places 10
Course Fee Life Sciences Members €600 / person
Subjects Taught 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
Course Content 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
Entry Requirements Working with quality systems
Further Enquiries Michelle Reinecke-Quain
Life Sciences Skillnet Administrator
Email: michelle.reinecke-quain@ibec.ie
Phone: 061 431802
Learning Outcomes 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
Trainer Irish Quality Centre Galway & Sligo
Kelamc Group Clonmel
Location of Course Sligo Radisson Blu
Limerick tba
Athlone tba
Available to Job Seekers: 
Yes
Certified: 
Yes

Quality Auditor Training

Network: 
HPSU Skillnet
Duration 4.5 days
Number of Places 12
Course Fee Please contact Philip Kelly
Subjects Taught As per course contents
Enrolment and Start Dates Comment Start and enrollment date is the 16th April 2013,
The course will be held on the following dates:
16th and 17th April,
23rd and 24th April
16th and 17th May
28th and 29th May
Financial Support Please contact Philip Kelly
Course Content Participants will learn to :
• Understand the ISO 9001:2008 standard requirements - value added approach.
• Apply auditing best practices using key principles, interpersonal skills and techniques.
• Plan for effective auditing and management system reviews
• Use the audit process and outcomes for QMS planning, management system improvements and bottom line results.
Further Enquiries Philip Kelly
Network Manager
m: 086 814 6060
e: hpsuskillnet@gmail.com
Learning Outcomes A working knowledge quality auditing
Location of Course Galway
Available to Job Seekers: 
Yes
Certified: 
No

ISO13485 Refresher Course

Network: 
Life Sciences Skillnet
Duration 1 day
Comment Introduction to ISO13485:2003 Medical Devices Directive
Book on line: Life Sciences - Book your event
Number of Places 15
Course Fee Life Sciences Skillnet members Members €150.00
Free of Charge to Job Seekers
Enrolment and Start Dates Comment Course runs on demand
Course Content Why change and what are the main new requirements
Structure & Content of ISO 13485:2003
Quality management system
Resource management
Product realisation
Measurement, analysis and improvement
Further Enquiries Michelle Reinecke-Quain
Life Sciences Skillnet Administrator
Email: michelle.reinecke-quain@ibec.ie
Phone: 061 431802
Learning Outcomes 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
Available to Job Seekers: 
Yes
Certified: 
Yes
Syndicate content