Establishing and Maintaining Data Integrity 

For the past 25 years computers, internet and immediate worldwide communications have revolutionised the way we live and work.  However, who among us has not had significant computer problems at home and in the workplace.  Yet we rightly require continuing perfection from our computers, their programs and data.

This seminar addresses the on-going integrity of these parameters in our workplace.  Expectations of both the workplace and Regulatory Agencies are that software and programs are fit for purpose and secure from inadvertent and deliberate input and output.  Computers are now used throughout the manufacture, testing and documentation of therapeutic goods.

Presentation include GMP requirements from TGA, what is data, and detailed aspects of manufacture, testing and documentations.

While this seminar should be of particular value to those involved with therapeutic goods, the presentations will surely be of interest and benefit to scientists of all disciplines and interest who rely on computers and their data.

PROGRAM
12.40 - 13.05 Registration

13.05 - 13.10 Chair seminar welcome and introduction
        Niesha Davis, Human Resources Business Partner, AstraZeneca
        and member, RACI Pharmaceutical Science Group (NSW) Committee

13.10 - 13.40 What is computer data and how can it be protected
        Dr Laura McKemmish, Researcher, UNSW

13.40 – 14.10 TGA Requirements
        Gaye Camm, Senior Inspector, Manufacturing and Quality Branch, TGA

14.10 - 14.40 Data integrity – Documentation – Batch documentation SOPs, logs etc
        Trevor Schoerie, Managing Director,  PharmOut

14.40 - 15.10 Data Integrity – equipment
        Seamus Orr, Technical Services Manager, AstraZeneca

15.10 - 15.30 Afternoon Tea 

15.30 - 16.00 Coding creation and scanning
        Bruce Botta, Packaging Technical Coordinator, Aspen Australia

16.00 - 16.30 The Data Integrity Challenges of Analytical Instrumentation
        Clayton Ross, Business development manager, Shimadzu

16.30 - 17.00 Data Protection
        Ian Ward, Managing Director, CyberPro Pty Ltd

17.00 - 17.15 Questions and discussion

17.15 Drinks and dinner

See Annex 11 Computerised Systems from the Annexes of the Code of Good Manufacturing Practice https://www.tga.gov.au/sites/default/files/pe009-14-gmp-guide-annexes.pdf


Registration Costs

RACI member including dinner              $175
RACI member not including dinner    $140
RACI member webinar                              $120

Non member including dinner            $225
Non member not including dinner      $190
Non member webinar                               $175

Student members                                    $10
Student non-members                      $30

Register here. 

Please note that registration fees will increase by 15% after COB, 17 October to encourage early registrations.

Follow the instructions and which fields to complete as an RACI member or non-member with care.  Members with an RACI account should enter their Username and Password and follow subsequent instructions.  Non-members will initially need to “Create a new account” and also follow subsequent instructions.

Registrations close at 12 noon, Friday 21 October. Due to webinar setup activities, later registration applications cannot be accepted.

For any queries on registration, contact the NSW Branch coordinator, Robyn Lewis - Tuesday to Thursday, phone 0466 269 811, email: [email protected]. 

For information about the program contact David Edmonds, Committee, RACI Pharmaceutical Science Group (NSW).
Email:  [email protected]

RACI Event number: 1360

Please note also that registration to the Data Integrity seminar/ webinar includes free attendance at the upcoming webinar on Hybrid Auditing.  This will be given before December 15, details to be advised.

Note: The Pharmaceutical Science Group reserves the right to omit or change presenters and/or presentations without prior notice to seminar/webinar attendees.  Also note that the Group may deny registration(s) if the venue or webinar licence capacity is filled with prior registrants.

The Group website is found here.