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Internal Quality Auditing for Manufacturers of Finished Pharmaceuticals

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 audit 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.

Delivery Mode

  • Customised
    In-Company
    Programmes

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Accreditation
Course Code
LS018

Duration
2 training days

What's covered?

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 requirements

Day 2

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

Who should participate?

  • 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?

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 1 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?

Kevina O’Donoghue

Kevina takes great pride in the training she delivers. She understands that supporting you effectively means meeting challenges and deadlines, understanding your specific needs, communicating effectively with you and providing accurate and honest advice, with integrity and confidentiality.

Kevina is a PhD graduate from the National University of Ireland, Galway. Since graduating she has worked in the life science industry for 20 years, both nationally and internationally. Beginning in the diagnostics sector, working for Cambridge Diagnostics she then moved to the medical device sector working for Abbott Vascular, Galway. Here she worked as a Microbiologist and was closely involved in the setting up, validation and monitoring of cleanroom environments.

Kevina delivers training programmes on many different topics related to Auditing, CE Marking, Quality Standards, Cleanroom Controls and Behaviours, GMP, as well as developing bespoke training programmes to meet specific client’s needs. Kevina’s outstanding attribute is her ability to motivate learners and enable their learning through sharing her knowledge and work-based experiences, in a simple and easy to understand way thus allowing the learners to achieve their learning goals successfully.

In addition to providing expert training, Kevina routinely works as a consultant and auditor. Kevina has the expertise to deal effectively with both Cleanroom, Quality and Regulatory related issues. Kevina is knowledgeable in many different quality and regulatory standards within the medical device, pharmaceutical, laboratory, & healthcare industries, is a strong and experienced auditor consistently challenging systems for compliance in a fair and consistent manner. With the wealth of experience Kevina has accumulated to date working with many different companies, she can appreciate and identify many similar situations thus allowing her to link examples and communicate clearly and effectively to ensure understanding.

Kevina provides key support to both start up and multinational companies. She is an accomplished trainer with a Certificate in Training and Continuing Education from NUI, Maynooth and has also successfully completed QMS Auditor / Lead Auditor training.


Kevina O’Donoghue

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Kevina O’Donoghue

Duration: 2 days
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Contact SQT today

Phone+353 61 339040

Mailinfo@sqt-training.com