Data Integrity Training Course

Data Integrity Training Course

Overview of the Data Integrity Overview Course

Data integrity is not new. It is implicit, and always has been, as a foundation of good manufacturing practice (GMP).

The subject of data integrity, however, has an increased profile because hybrid (paper and electronic), digital technologies and electronic systems have become prevalent in modern manufacturing.

Globally regulators are recruiting and training their Regulatory Compliance Inspectors in data integrity.  During GMP compliance audits, Inspectors are identifying increasing numbers of GMP violations linked to data integrity.

  • This one-day Data Integrity training course is regularly offered in Adelaide, Brisbane, Melbourne, Perth and Sydney (Australia) and in Auckland (NZ) and Hong Kong.
  • The course 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.

What you will learn in our 1-Day Data Integrity training course:

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
  • Embedding 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.

GMP Certificate Training & Course Materials

  • Participants in this training course will receive a copy of the copyrighted presentation(s), relevant notes and workshop materials.
  • A certificate of completion will be issued to participants who successfully complete the assessment.
  • Assessment

Course format

  • The course is a combination of lecture-style learning and highly interactive workshops with participants working in small groups on assigned tasks.
  • A written assessment is conducted at the end of the course.

Who should attend?

  • Quality Assurance personnel
  • Quality Control personnel
  • Operations and Manufacturing personnel
  • Qualification/Validation personnel
  • Engineering & Automation personnel
  • Regulatory Affairs personnel
  • Anyone within the GMP industry interested in learning about or improving their knowledge of current PIC/S GMPs.

AUD $450.00 + 10% GST ($495 AUD)

Prices are per person and include morning tea, lunch and afternoon tea.

Register for a Data Integrity Training Course below:

If you need any assistance, would like a quote for personalised group training or just have a general training question don’t hesitate to contact us.