- Data Integrity Training (MEL-08-05-18)
9:00 am - 4:00 pm
Melbourne Data Integrity Training Course
The requirements around Data integrity are not new. It is implicit, and always has been s 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 designed to provide an overview of the latest concepts and guidance documents for Data Integrity including the MHRA, US FDA Data Integrity and Compliance with cGMP Guidance for Industry released in April 2016 and other regulations including PIC/S GMP and US FDA 21 CFR 11 and 211.
The course will be delivered by Trevor Schoerie, who has attended conferences and seminars on Data Integrity supported by various global regulators, including the US FDA in Washington DC, the MHRA in London and the TGA in Australia. Trevor has presented on the topic at a Parenteral Drug Association (PDA) Data Integrity event in Melbourne as well as at training events around Australia and Asia. Trevor has advised companies on approaches for ensuring Data Integrity, and is considered a GAMP5 expert.
This course offer 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.
We regularly offer Data Integrity training courses and events in Adelaide, Auckland, Brisbane, Hong Kong, Melbourne, Perth and Sydney, or in other countries on as needed basis.
Venue: PharmOut Training Centre
Venue Phone: +61 3 9887 6412Address: