Data Integrity Training Course
Data integrity is not new, it is implicit, and always has been, as a foundation of good manufacturing practice. 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.
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.
Participants will receive 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.
A written assessment is conducted at the end of the course.
The course is a combination of lecture-style learning and highly interactive workshops with participants working in small groups on assigned tasks.
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$400.00 + 10% GST
Bring Your Own Device (BYOD)
To offer you this unique, cost effective training, we have combined two of our aspirational organisational goals, Paperless and Innovation, for you to attend you must bring your own device and we will supply an internet connection, WiFi will be provided free of charge in all venues.
Prices are per person and includes 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.
|Melbourne Data Integrity Training||PharmOut Training Centre||
|Sydney Data Integrity Training Course||Eden Gardens and Garden Centre - Sydney||
Course Code: PO1805