Internal Quality Auditing for Manufacturers of Active Pharmaceutical 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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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.

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.

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

Kevina O’Donoghue

Kevina takes great pride in the training she delivers. She unde...

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Snapshot

Course Code

LS017

Duration

2 training days

Delivery Mode

Available for In-House and delivered through virtual classroom training.

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Internal Quality Auditing for Manufacturers of Active Pharmaceuticals Ingredients

Introduction

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

What's covered?

Who should participate?

What will I learn?