09 - 10 April, 2019 | Novotel Sydney Central, Sydney, Australia

Michael Dornbusch


Assistant Secretary
Office of the Gene Technology Regulator


1:20 PM CASE STUDY: Understanding the Regulations and Standards to Secure Facility Certification

Many considerations are factored in to the design and development of new and existing facilities. From location to physical features, to safety and operations of activities within the building. The most pressing consideration is ensuring that the project complies with current regulations and puts the health and safety of people at the forefront of the plan. Particularly, gene technology is a rapidly developing field of science and the use of genetically modified organisms (GMOs) are subject to regulations set by the OGTR.

Design principles and risk assessments that take place during the planning stages of building or renovating infrastructure are not always clear especially when different regulations apply to different areas of scientific discipline. In this session, you will develop an understanding of the standards to ensure your facility is aligning with biosafety and biotechnology principles and practices.

  • Overview of the standards and regulatory requirements relevant for design and operation of facilities for work with GMOs
  • Developments in regulatory requirements for certified facilities
  • Securing facility certification and how to maintain it

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