Introduction to Auditing
Average Pass Rate: 88.9% | 2 attempts available to pass the final assessment.
Auditing is the on-site verification activity (such as inspection or examination) of a process or quality system, to check compliance or non-compliance to the specified requirements of the standard as outlined in the Human Medicine Regulation (2012).
Audits are carried out against the GDP Guidelines 2013/C 343/01 prior to trading with a company, or in response to a triggering event such as performance failures.
This course will cover Quality Management, the requirements and role of a qualified and competent auditor and the tasks and types of auditing, in line with the GDP Guidelines 2013/C 343/01.
The learning objectives of our Introduction to Auditing course are:
- To understand the importance and requirements of Quality Management, against the principles of ISO 9001 and PQMS.
- Understand what an Audit is, what types of audit you may experience, and how to prepare for the audit day.
- Understand the role of the Auditor and how the GDP Guidelines 2013/C 343/01 apply to their role.
You will also learn:
- Types of deficiency.
- What should be covered at a closing meeting.
- What follow-up processes should be undertaken after an audit.
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Ratings and Reviews
Richard Peck
Great course to understand the reasons and importance of doing audits, and the principles for executing a good audit.
ben.hepworth@clarity-pharma.com
Expected the course to take longer. Tests after each section ensured the knowledge being assessed was fresh in my mind. Some questions were vague and didn't relate entirely to the content of the course. Overall very happy with the course and feel more confident stepping into an auditor role.
Kavita Jesani
Really enjoyed that this course can be completed in your own time, pre-test is a nice touch to see what you basic understanding is prior to taking the course. Content is very informative, will be saving notes for future use and returning for a refresher next year. Thanks Paradigm Shift.
Compact introduction in GDP. It would be nice to touch more subjects.