Event

SeerPharma Symposium

  • 06 Sep 2018-07 Sep 2018
  • 09:00AM-17:00PM
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  • Park Hyatt, Sydney, NSW, Australia

SeerPharma



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About the Event

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.