On site Data Integrity Training Course

On site Data Integrity Training Course

Overview

Data integrity is not new, it is implicit, and always has been, as a foundation of good manufacturing practice so its important to attend a formal Data Integrity training course. The subject however has an increased profile as hybrid (paper and electronic) and electronic systems become more prevalent in modern manufacturing. Globally regulators are recruiting and training their inspectors in data integrity and they are identifying increasing numbers of GMP violations linked to data integrity.

This one-day Data Integrity training course is regularly offered in Auckland, Adelaide, Brisbane, Hong Kong, Melbourne, Perth and Sydney. It is designed to provide an overview of the latest concepts and guidance documents for Data Integrity including the FDA Data Integrity and Compliance with cGMP Guidance for Industry, released in April 2016, and regulations in PIC/S GMP and 21 CFR 11 and 211.

This course offers a practical insight into data integrity, what it is and how you can develop systems to help protect your employees and organisations form deliberate and unintentional data integrity compliance issues.

Course Duration & Location

One day, on your site or at an offsite location.

PharmOut’s cutting edge Data Integrity training courses can be delivered anywhere in the world, we will ask you to cover reasonable travel costs, with this you will save the costs associated with your staff travelling to a external venue to be trained, so it becomes cost effective if you have several people needing training.

Pricing

Our 2018 pricing is A$350 per person or A$3500 per day plus GST for up to 15 participants. This does not include travel costs.

*Smart device and WiFi is needed for all attendees.

Contact us for a quote if you need more that 10 trainees to be trained.

What you will learn

Upon completion of this data Integrity training course participants will understand;

  • What is data integrity and why is it important
  • Deep dive into FDA warning letters
  • The ALCOA principles
  • Relationship between good documentation practices and data integrity
  • Data integrity in laboratories
  • Security including user access, privileges, audit trails, archiving and retrieval
  • Imbedding data integrity into your quality systems- it is not a stand-alone policy!
  • The course is designed around case studies so you can practically apply theory to real life.

Course materials

Participants will receive a workbook with will contain a copy of the presentation(s), relevant notes and workshop materials.

A certificate of completion will be issued to participants who successfully complete the assessment.

Assessment

A written assessment is conducted at the end of the course.

Course Format

The GMP Training Course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.

Who should attend?

  • Quality Control personnel
  • Quality Assurance personnel
  • Operations and Manufacturing personnel
  • IT professionals

More information

If you would like a quote or would need to ask questions, please contact us.

Public Courses and Events

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Event Venue Date
Melbourne Quality Management Systems - ISO13485 Training Canterbury International Hotel
  • 05/06/2019 9:00 am
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Melbourne ISO 14971 Quality Risk Management Training Canterbury International Hotel
  • 06/06/2019 9:00 am
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Melbourne Cleaning Validation Training Canterbury International Hotel
  • 07/06/2019 9:00 am
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Melbourne Process Validation Training Canterbury International Hotel
  • 12/06/2019 9:00 am
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Auckland PIC/S PE009 GMP Novotel Auckland Airport
  • 13/06/2019 9:00 am
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Sydney Quality Risk Management Training (ICH Q9) Eden Gardens and Garden Centre - Sydney
  • 20/06/2019 9:00 am
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Sydney Process Validation Training Eden Gardens and Garden Centre - Sydney
  • 03/07/2019 9:00 am
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Sydney Statistics for Process Validation Training Eden Gardens and Garden Centre - Sydney
  • 04/07/2019 9:00 am
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Melbourne CAPA Training Canterbury International Hotel
  • 09/07/2019 9:00 am
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Melbourne Process Validation Training Canterbury International Hotel
  • 10/07/2019 9:00 am
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Melbourne Statistics for Process Validation Training Canterbury International Hotel
  • 11/07/2019 9:00 am
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Perth Self Inspection (internal audit) Training Novotel Langley - Perth
  • 12/07/2019 9:00 am
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Auckland Medicinal Cannabis Cultivation Training Course Novotel Auckland Airport
  • 19/07/2019 9:00 am
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GMP & Engineering Forum 2019 - Attendees Pullman Melbourne On The Park
  • 22/07/2019 8:30 am
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GMP & Engineering Forum 2019 - Sponsors Pullman Melbourne On The Park
  • 22/07/2019 8:30 am
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Melbourne Medicinal Cannabis Cultivation Training Course Canterbury International Hotel
  • 24/07/2019 9:00 am
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Sydney Medicinal Cannabis Cultivation Training Course Eden Gardens and Garden Centre - Sydney
  • 26/07/2019 9:00 am
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Melbourne Good Distribution Practice Canterbury International Hotel
  • 30/07/2019 9:00 am
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Melbourne GAMP & Computerised Systems Validation Training Course Canterbury International Hotel
  • 31/07/2019 9:00 am
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Adelaide GMP SOP Technical Writing Training The Lion Hotel - Adelaide
  • 01/08/2019 9:00 am
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Adelaide CAPA Training The Lion Hotel - Adelaide
  • 02/08/2019 9:00 am
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Sydney Self Inspection (internal audit) Training Eden Gardens and Garden Centre - Sydney
  • 07/08/2019 9:00 am
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Sydney CAPA Training Eden Gardens and Garden Centre - Sydney
  • 08/08/2019 9:00 am
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Melbourne Good Laboratory Practice Training Canterbury International Hotel
  • 13/08/2019 9:00 am
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Melbourne PIC/S PE009 GMP Canterbury International Hotel
  • 15/08/2019 9:00 am
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Sydney GMP SOP Technical Writing Training Eden Gardens and Garden Centre - Sydney
  • 22/08/2019 9:00 am
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Auckland CAPA Training Novotel Auckland Airport
  • 29/08/2019 9:00 am
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Melbourne GMP SOP Technical Writing Training Canterbury International Hotel
  • 03/09/2019 9:00 am
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Melbourne Self Inspection (internal audit) Training Canterbury International Hotel
  • 24/09/2019 9:00 am
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Sydney PIC/S PE009 GMP Eden Gardens and Garden Centre - Sydney
  • 26/09/2019 9:00 am
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Melbourne Data Integrity Training Canterbury International Hotel
  • 29/10/2019 9:00 am
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Sydney Data Integrity Training Course Eden Gardens and Garden Centre - Sydney
  • 31/10/2019 9:00 am
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Melbourne CAPA Training Canterbury International Hotel
  • 12/11/2019 9:00 am
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Melbourne GMP Facility Design Canterbury International Hotel
  • 15/11/2019 9:00 am
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Sydney GMP Facility Design Eden Gardens and Garden Centre - Sydney
  • 20/11/2019 9:00 am
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Sydney CAPA Training Eden Gardens and Garden Centre - Sydney
  • 21/11/2019 9:00 am
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Perth CAPA Training Novotel Langley - Perth
  • 28/11/2019 9:00 am
Register