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Stephen Farrell

Director, GMP Clearance, Manufacturing Quality Branch (MQB) Therapeutic Goods Administration (TGA), Australia

Stephen is the Director of the GMP Clearance section of the Manufacturing Quality Branch and joined the TGA from industry in January 2016.

Prior to this, Stephen had over 10 years of experience in manufacturing facilities in both Europe and Australia across several categories of Therapeutic Goods including medical devices, biological drug substances, terminally sterilised and aseptically prepared dosage forms and radiopharmaceuticals.

Stephen is one of the TGA’s members of the PIC/S Committee of Officials and the chair of Inspection Reliance Working Group which is leading efforts on increasing the use of GMP inspection reliance practices amongst PIC/S participating authorities.

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See Stephen Farrell at this event

  • Day 2 Wednesday 4 December

Reliance across the product life cycle: PACs & GMPs

Session objectives:

  • Discuss how reliance can be implemented for PACs and what tools are available to streamline reliance in this area.
  • Highlight findings from literature, industry surveys and available data to illustrate the complexity of the current global PACs framework.
  • Address challenges and propose solutions to further implement reliance for GMP inspections.

Speakers