A SME’s Guide to Good Manufacturing Practice

Are you an Australian manufacturer of medical devices, medicines or biologicals? If so, you are no doubt aware that your manufacturing licence requires compliance with the relevant code of Good Manufacturing Practice (GMP).

Join us for this unique event where we will explore the basic principles behind Good Manufacturing Practice and ISO 13485, and hear from representatives from AIRO and Orthocell, two companies that have successfully made the quality journey to having certified quality management systems.

We’ll answer:

• What are the key elements of GMP and ISO 13485?
• Who in your start up is responsible for GMP?
• How do I prepare for an on-site inspection?
• What are some examples of GMP violations?
• What happens if I don’t get my GMP compliance?

Keep the conversation going with light food and drinks provided after the formalities.

Speakers

• Dr Janet Preuss, Managing Director, Biotech Recruitment Consultants
• Richard Chipper, Chief Technology Officer, Australian Institute of Robotic Orthopaedics (AIRO)
• James Hill, Chief Operating Officer, Singular Health
• Monique Cannon, Quality Director, Orthocell

Chairperson

• Professor Kevin Pfleger, Director, Biomedical and Health Innovation at The University of Western Australia and WA Life Sciences Innovation Hub

Sponsored by Deloitte