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Pharmaceutical Quality Systems (PQS) Internal Auditor

August 12 @ 8:00 am - August 13 @ 5:30 pm

€599
PQMS-Internal-Auditor

Two day PQS Internal Auditor Training.

Plan and prepare effectively for internal cGMP auditing within the Pharmaceutical Quality System.

Learn how to:

  1. Gather objective evidence, through effective interviewing, observation, sampling and note taking.

  2. Analyse and interpret information in order to determine conformance with requirements, effectiveness, and, areas for improvement.

  3. Report the audit, including writing valid, factual and value-adding audit reports.

  4. Undertake audit follow-up activities, including evaluating the effectiveness of corrective action.

Trainees will learn the necessary skills to be able to plan, perform, report and improve in relation to all audits and inspections. They will also learn how to liaise appropriately with outside regulatory bodies and to represent your organisation during inspections and whilst auditing your suppliers, in a professional, thorough and fair manner.

Who should attend

Quality Managers and those with internal auditing / self inspection responsibilities across all departments.

Those who want to pursue a career as an Auditor.

Course Objectives (Summary)

Describe the purpose of a pharmaceutical quality system.

Interpret requirements  of ICH, EU and USFDA guidelines and regulations and GMP’s in the context of an audit.

Plan and conduct an audit in accordance with ISO 19011, demonstrating ability to…

  • Plan and prepare effectively

  • Gather objective evidence, through effective interviewing, observation, sampling and note taking.

  • Analyse and interpret information in order to determine conformance/compliance 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.

Tickets

12 available
PQS Internal Auditor - April 599PQS Internal Auditor Training.

Details

Start:
August 12 @ 8:00 am
End:
August 13 @ 5:30 pm
Cost:
€599
Courses Categories:
,

Organiser

Philip Byrne

Venue

Dublin
Maldon Hotel Newlands Cross, Naas Road, Newlands Cross
Dublin 22, Co. Dublin D22 V6Y6 Ireland
+ Google Map
Phone:
+35314640140
Website:
https://www.maldronhotelnewlandscross.com/