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Achieving Confidence in Compliance

06 - 07 September 2018  |  Sydney
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Overview

In 2016 we held our inaugural Symposium in Melbourne, while in 2017 we took it to Singapore. This year, we're excited to bring our premiere event to Sydney. This year's event is aimed towards Medical Device and Pharmaceutical professionals that are involved in Quality Assurance (QA) and Compliance. 

Day 1 will focus on QA/Compliance needs for the Medical Device industry. We'll take on topics such as managing Design History Files (DHF), Risk Management and Post Market Responsibilities. We're also excited to bring you the latest on Cybersecurity from UL and their work with the US FDA, and implications towards connected Medical Devices.  We're thrilled to also have the Australian regulatory body for therapeutic goods - the TGA -  present on Market responsibilities for Medical Device Sponsors. Plus we're privileged to have Notified Body - BSI, discuss what they consider to be "Effective Implementation of ISO13485:2016" , sharing their experience of auditing and certifying Medical Device companies to this standard.

Day 2 will address topics on QA/Compliance for those of you dealing with Pharmaceuticals. We'll look to address topics such as managing your CAPA's, Computer System Validation (CSV) and Supplier Qualification / Supplier Assurance.  Leaning on our 30 years of industry experience , we're excited to also address how you should best prepare for a Regulatory GMP Inspection. We'll look at the approaches and differences between a PIC/S  and US FDA GMP Inspections, and hopefully provide you with some ideas on how best to prepare your staff for managing a regulator on site. We're also honoured to have GS1 present on the latest standards and work that they've been putting in with the US FDA on securing drug supply through Track and Trace, which we will look to tie in to our presentation on Supplier Quality Assurance.

In addition to all this, we're really excited about holding the Symposium at the Park Hyatt, in Sydney. Situated at The Rocks, below the Sydney Harbour Bridge, you'll have spectacular views of the Harbour and Sydney Opera House during this 2-day event.  

We look forward to hosting you at this wonderful location and hopefully at the end of it, you will have achieved greater Confidence In Compliance.

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Proposed Speakers

  • Mr Tony Rowland, SeerPharma Partner 
  • Mr Paul Kerr, SeerPharma Partner
  • Ms Louise White, SeerPharma Partner
  • Mr Andrew Giles, SeerPharma Senior Consultant (former TGA GMP Inspector)
  • Mrs Jacqueline Berry, SeerPharma Senior Consultant
  • Mr Daniel Flewellen, SeerPharma Senior Consultant
  • Mr Rohan Bhatia, SeerPharma Business Systems Project Manager
  • Mr Andrew Jamieson, Technology and Security Director, Identity Management & Security,  UL
  • Dr Kelly Tsang,  Assistant Director, TGA - Medical Devices Branch
  • Mr Dushyant Sanathara, Team Manager, Medical Devices and Product Certification, BSI
  • Ms Catherine Koetz, Industry Manager - Healthcare, GS1

Proposed Program

[fa icon="plus-square"] Day 1 | Medical Devices
  • Achieving Quality Management System Certification 
  • Addressing the Culture of Quality in your Organisation
  • Cybersecurity (UL)
  • Design History Files 
  • Risk Management for Medical Devices (ISO 14971)
  • Electronic Quality Management Systems
  • Effective Implementation of ISO 13485:2016 (BSI)
  • Post Market Responsibilities (TGA)
[fa icon="plus-square"] Day 2 | Pharmaceuticals
  • Achieving Quality Management System Certification
  • Addressing the Culture of Quality in your Organisation
  • How to face a PIC/S or FDA GMP Inspector
  • Adoption of PIC/S GMP Guide Version 13
  • Supplier Qualification / Supplier Assurance
  • Track and Trace - Securing Drug Supply (GS1)
  • Computer System Validation
  • How to Manage CAPAs
The full list of Speakers and a detailed Program will be published soon.
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Dates and Times

06 - 07 September 2018  |  8:30am to 5:00pm

Food and refreshments will be provided throughout the days.

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Venue

Park Hyatt Sydney

7 Hickson Road, The Rocks

Sydney, New South Wales 2000

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Fee (AUD | ex GST)

Early bird registration (until 31 July 2018)

$500 per day

Standard registration (from 01 August 2018)

$600 per day

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