Internal Quality Auditing for Manufacturers of Active Pharmaceuticals Ingredients

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This programme is available In-House and currently delivered through virtual classroom training. Internal auditing is fundamental to any quality improvement initiative. In particular, the FDA cGMP’s for Pharmaceutical Products require that an organ... Read More

This programme is available In-House and currently delivered through virtual classroom training.

Internal auditing is fundamental to any quality improvement initiative. In particular, the FDA cGMP’s for Pharmaceutical Products require that an organisation conduct internal quality audits to determine the effectiveness of its quality system. EU GMP requirements expect that companies conduct self inspections. Trained auditors must carry out these audits.

Thousands of internal audits are performed each year providing little internal business benefit. This course focuses on auditing company quality systems for real quality improvement rather than just compliance.

This two day course provides detailed training in developing the skills necessary to be an effective internal auditor.

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What's covered?

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Please Note: A practical audit within the company forms the basis of day 2. Audit areas within the company must be organised prior to the training so that effective preparation can commence on day 1.  For this reason the numbers on this course are restricted to max 12 (4 audit groups of 3) to ensure all delegates get the attention needed to ensure they become effective Auditors.

Day 1

  • Introduction to Quality Systems
  • Purpose of Internal Quality Audits
  • The Audit Process
  • Selecting the Audit Team
  • Tools available to Auditors
  • Audit Preparation
  • FDA CFR part 211 cGMP for Pharmaceuticals & additional EU GMP Part II requirements

Day 2:

  • Audit Preparation (Follow on from Day 1)
  • Audit Performance
  • Evaluating & Reporting the Audit

Delegates must attend both days to receive a Certificate of Attendance.

Who should participate?

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  • Any person in the organisation with responsibility for conducting internal audits
  • Departmental managers and supervisory staff
  • Quality Managers, quality engineers and supervisory staff
  • Staff with responsibility for designing and implementing quality systems
  • Personnel responsible for supplier / external audits.

What will I learn?

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Participants achieve the following learning outcomes from the programme;

  • Understand the requirements of the FDA CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals & EU GMP Part II requirements
  • Understand the importance of internal auditing within a quality management system
  • Understand the responsibilities of Internal Auditors
  • Conduct an effective internal audit e.g. plan and organise an internal audit against the organisation’s documented procedures
  • Collect and analyse evidence objectively
  • Evaluate and report the results of an internal audit

Who are the tutors?

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Share this Programme

SnapshotSnapshot

Course Code
LS017
Duration
2 training days
Delivery Mode
Available for In-House and delivered through virtual classroom training.
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What Our Learner's SayWhat Our Learner's Say



Overall, I found this training course to be excellent and very much hands on. The pace of the training was good, and the trainer was very knowledgeable, competent and friendly. The organisation was well managed and I would recommend this course in future to others looking to develop skills in this area.
Padraic M November 22, 2023
Really enjoyed the two days, took a lot of learnings from itand it has given me more confidence and skills to perform an internal audit
Hazel O November 22, 2023
Great course overall, I learned a lot
orla W November 22, 2023
Very interactive, hands on course. Kevina is very knowledgeable in the area. Thoroughly enjoyed.
Orla M November 22, 2023

Internal Quality Auditing for Manufacturers of Active Pharmaceuticals Ingredients

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Internal Quality Auditing for Manufacturers of Active Pharmaceuticals Ingredients

Duration: 2 days
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