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Overview

SeerPharma are passionate about Quality Management as the work we and our customers do, helps ensure that medical devices and pharmaceuticals are safe, effective and of an acceptable quality.

By virtue of the work that we do and having been around for close to 30 years, we are now connected to over 2000 organisations involved in the supply chain of pharmaceuticals and/or medical devices in the Asia-Pacific region.

The SeerPharma Symposium is our premier event presenting Quality professionals in the Pharmaceutical and Medical Device industries an opportunity to connect, share and collaborate.

Quality Management issues in the Pharmaceutical and Medical Device industries are at the heart of the problems we solve here at SeerPharma. Our tagline is “Confidence in Compliance” but to achieve this, companies must practice Total Quality Management.

The 2019 Symposium will tackle key problems that Quality professionals face in the Pharmaceutical and Medical Device industries. The event will look to get the most out of your Quality Management System and address a wide variety of topics such as employee culture, managing your CAPA's effectively and Computer System Validation.

We're excited to have a former FDA Manager present on how to make Quality Compliance easier, and also provide insights on maintaining Data Integrity.  Hear from Notified Body, BSI, present on the latest version of ISO 13485, plus their thoughts on MDSAP and EU MDR.  Plus GS1 will provide us an overview on their latest work with the US FDA on Track and Trace. We'll  also have an ex-TGA GMP Inspector present on how best to prepare for and handle a GMP regulatory inspection.

Having held the event in Melbourne (2016), Singapore (2017) and Sydney (2018), it's time to bring this event to Kuala Lumpur, Malaysia – further cementing our reputation as Asia-Pacific’s Leader in Quality Assurance and GMP compliance.

We're excited to be holding this event at the exclusive Mandarin Oriental in Kuala Lumpur, at the footsteps of the iconic Petronas Twin Towers.

We look forward to hosting you at this wonderful location and hopefully at the end of it, you will have some of  the tools required to practice Total Quality Management.

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Speakers

  • Bryant Headley, Customer Success Executive (ex- FDA Manager, Office of Regulatory Affairs), MasterControl
  • Kenny Chong, Healthcare Sector Technical Lead - BSI
  • Leong Kah Leon, Executive, GS1 Malaysia Berhad
  • Andrew Giles,  Senior Consultant (former TGA GMP Inspector), SeerPharma 
  • Paul Kerr, Director, SeerPharma
  • David Spaulding, Director and Training Manager, SeerPharma
  • Jacqueline Berry, Senior Consultant, UTS (Master of GMP) Lecturer, SeerPharma
  • Rohan Bhatia, Business Systems Project Manager, SeerPharma
  • Gloria Pang, Senior Consultant, SeerPharma (Singapore) 

Moderator : Biju Kishor, Sales and Marketing Manager, SeerPharma

Agenda

[fa icon="plus-square"] Day 1 | Medical Devices
  • ISO 13485:2016 – Show or Performance? (BSI)
  • Addressing the Culture of Quality - Part I
    Influencing and supporting a culture that embraces quality assurance
  • Cybersecurity
  • Former FDA Manager Spills the Beans on Making Compliance Easier (MasterControl)
  • Latest on MDSAP and EU MDR (BSI)
  • Electronic Quality Management Systems – Automating Document Management
  • Conducting Internal Audits
[fa icon="plus-square"] Day 2 | Pharmaceuticals
  • Pharmaceutical Quality Management System
  • Addressing the Culture of Quality - Part II
    Influencing and supporting a culture that ensures human error is understood and minimised
  • Preparing for a GMP Inspection (former TGA GMP Inspector)
  • Electronic QMS – Automating Your CAPA Workflow
  • Former FDA Insider Reveals the One Thing You Need to Maintain Data Integrity (MasterControl)
  • Fulfilling the National Healthcare & Pharmaceutical Track & Trace Roadmap using GS1 Standards
  • Computer System Validation
Download the Program
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When

Day 1 : Monday 8th July 2019 (Medical Devices)

Day 2:  Tuesday 9th July 2019 (Pharmaceuticals)

Attendees are welcome to attend one or both days.

Each day will run 8:30 am to 5 pm.

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Where

The event will be held at Mandarin Oriental, Kuala Lumpur.

Set between the flowering gardens of the KLCC Park and the dramatic heights of the Petronas Twin Towers, Mandarin Oriental, Kuala Lumpur is a 5-star luxury hotel that offers impressive views, fabulous facilities and a convenient central location.

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Cost

AUD $500 per day (exc. GST)

Group discounts (AUD$400 per delegate per day) are available for 3 or more delegates from a company.

Note : 1 AUD is approximately 3 MYR

Morning Tea, Working Lunch and Afternoon Tea provided by the Mandarin Oriental Group

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