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

Find a public course or event in a city near you –

Search:

EventVenueDate
Sydney Good Distribution PracticeEden Gardens and Garden Centre - Sydney
  • 07/02/2019 9:00 am
Register
Auckland Process Validation & Statistics for Process ValidationNovotel Auckland Airport
  • 07/02/2019 9:00 am
Register
Perth GMP SOP Technical Writing TrainingNovotel Langley - Perth
  • 22/02/2019 9:00 am
Register
Brisbane GMP SOP Technical Writing TrainingNovotel Brisbane
  • 27/02/2019 9:00 am
Register
Sydney GMP SOP Technical Writing TrainingEden Gardens and Garden Centre - Sydney
  • 28/02/2019 9:00 am
Register
Melbourne Process Validation TrainingPharmOut Training Centre
  • 05/03/2019 9:00 am
Register
Brisbane Self Inspection (internal audit) TrainingNovotel Brisbane
  • 06/03/2019 9:00 am
Register
Perth GAMP & Computerised Systems Validation TrainingNovotel Langley - Perth
  • 07/03/2019 9:00 am
Register
Australian Medicinal Cannabis ConferenceSofitel Melbourne on Collins
  • 25/03/2019 9:00 am
Register
Adelaide CAPA TrainingThe Lion Hotel - Adelaide
  • 05/04/2019 9:00 am
Register
Perth CAPA TrainingNovotel Langley - Perth
  • 11/04/2019 9:00 am
Register
Melbourne PIC/S PE009 GMPPharmOut Training Centre
  • 16/04/2019 9:00 am
Register
Sydney PIC/S PE009 GMPEden Gardens and Garden Centre - Sydney
  • 02/05/2019 9:00 am
Register
Auckland Medicinal Cannabis Cultivation Training CourseNovotel Auckland Airport
  • 03/05/2019 8:00 am
Register
Sydney Medicinal Cannabis Cultivation Training CourseEden Gardens and Garden Centre - Sydney
  • 08/05/2019 8:00 am
Register
Melbourne Good Distribution PracticePharmOut Training Centre
  • 09/05/2019 9:00 am
Register
Melbourne Medicinal Cannabis Cultivation Training CourseNovotel Melbourne Glen Waverley
  • 10/05/2019 8:00 am
Register
Sydney GAMP & Computerised Systems Validation TrainingEden Gardens and Garden Centre - Sydney
  • 10/05/2019 9:00 am
Register
Sydney GMP Facility DesignEden Gardens and Garden Centre - Sydney
  • 14/05/2019 9:00 am
Register
Melbourne GMP Facility DesignPharmOut Training Centre
  • 16/05/2019 9:00 am
Register
Melbourne CAPA TrainingPharmOut Training Centre
  • 17/05/2019 9:00 am
Register
Sydney Cleaning Validation TrainingEden Gardens and Garden Centre - Sydney
  • 04/06/2019 9:00 am
Register
Melbourne Quality Management Systems - ISO13485 TrainingPharmOut Training Centre
  • 05/06/2019 9:00 am
Register
Melbourne ISO 14971 Quality Risk Management TrainingPharmOut Training Centre
  • 06/06/2019 9:00 am
Register
Melbourne Cleaning Validation TrainingPharmOut Training Centre
  • 07/06/2019 9:00 am
Register
Melbourne GMP SOP Technical Writing TrainingPharmOut Training Centre
  • 14/06/2019 9:00 am
Register
Melbourne Quality Risk Management Training (ICH Q9)PharmOut Training Centre
  • 18/06/2019 9:00 am
Register
Sydney Quality Risk Management Training (ICH Q9)Eden Gardens and Garden Centre - Sydney
  • 20/06/2019 9:00 am
Register
Melbourne GAMP & Computerised Systems Validation Training CoursePharmOut Training Centre
  • 21/06/2019 9:00 am
Register
Sydney Quality Management Systems - ISO13485 TrainingEden Gardens and Garden Centre - Sydney
  • 27/06/2019 9:00 am
Register
Sydney ISO 14971 Quality Risk Management TrainingEden Gardens and Garden Centre - Sydney
  • 28/06/2019 9:00 am
Register
Sydney Process Validation TrainingEden Gardens and Garden Centre - Sydney
  • 03/07/2019 9:00 am
Register
Sydney Statistics for Process Validation TrainingEden Gardens and Garden Centre - Sydney
  • 04/07/2019 9:00 am
Register
Melbourne Good Laboratory Practice TrainingPharmOut Training Centre
  • 09/07/2019 9:00 am
Register
Melbourne Process Validation TrainingPharmOut Training Centre
  • 10/07/2019 9:00 am
Register
Melbourne Statistics for Process Validation TrainingPharmOut Training Centre
  • 11/07/2019 9:00 am
Register
Sydney Good Laboratory Practice TrainingEden Gardens and Garden Centre - Sydney
  • 12/07/2019 9:00 am
Register
Sydney Self Inspection (internal audit) TrainingEden Gardens and Garden Centre - Sydney
  • 07/08/2019 9:00 am
Register
Sydney CAPA TrainingEden Gardens and Garden Centre - Sydney
  • 08/08/2019 9:00 am
Register
Sydney GMP SOP Technical Writing TrainingEden Gardens and Garden Centre - Sydney
  • 23/08/2019 9:00 am
Register
Auckland CAPA TrainingNovotel Auckland Airport
  • 30/08/2019 9:00 am
Register
Sydney PIC/S PE009 GMPEden Gardens and Garden Centre - Sydney
  • 19/09/2019 9:00 am
Register
Melbourne PIC/S PE009 GMPPharmOut Training Centre
  • 24/09/2019 9:00 am
Register
Melbourne Data Integrity TrainingPharmOut Training Centre
  • 03/10/2019 9:00 am
Register
Sydney Data Integrity Training CourseEden Gardens and Garden Centre - Sydney
  • 10/10/2019 9:00 am
Register
Melbourne CAPA TrainingPharmOut Training Centre
  • 12/11/2019 9:00 am
Register
Brisbane CAPA TrainingNovotel Brisbane
  • 14/11/2019 9:00 am
Register
Melbourne GMP Facility DesignPharmOut Training Centre
  • 15/11/2019 9:00 am
Register
Sydney GMP Facility DesignEden Gardens and Garden Centre - Sydney
  • 20/11/2019 9:00 am
Register
Sydney CAPA TrainingEden Gardens and Garden Centre - Sydney
  • 22/11/2019 9:00 am
Register
Adelaide CAPA TrainingThe Lion Hotel - Adelaide
  • 27/11/2019 9:00 am
Register
Perth CAPA TrainingNovotel Langley - Perth
  • 28/11/2019 9:00 am
Register