Onsite Data Integrity Training Course
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.
Duration & Location – Onsite Data Integrity Training Course
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.
PRICE: GMP Audit Training Costs | Certificate Course Options
Pricing per course is A$400 per person or A$4,000 per day plus GST for up to 15 participants.
This does not include travel costs.
*Smart device and WiFi may be needed for attendees for certain courses. If so, this will be designated in your registration confirmation materials.
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.
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.
A written assessment is conducted at the end of the course.
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
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 –
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|GMP & Engineering Forum 2019 - Sponsors||Pullman Melbourne On The Park||
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|Melbourne PIC/S PE009 GMP||Canterbury International Hotel||
|Melbourne Self Inspection (internal audit) Training||Canterbury International Hotel||
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|Melbourne Data Integrity Training||Canterbury International Hotel||
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