A02. Update from the Manufacturing Quality Branch
Tracks
GMP/Manufacturing
| Wednesday, June 12, 2024 |
| 11:15 AM - 12:15 PM |
| Parkside 2 |
Chair & Speakers
Kerry Dranganoudis
President / Director
ISPE Australasia and Compliance Connection
Chair: Update from the Manufacturing Quality Branch - TGA
Abstract
What's new, current and upcoming for Therapeutic Goods Regulation.
The Manufacturing Quality Branch, TGA has a wide range of regulatory responsibilities covering manufacturing sites, quality requirements for unapproved medicines and recall activities. This session will outline the Branch’s high priority topics and plans for the next 12 months.
The effect of the COVID-19 pandemic on global GMP inspections continues to affect the GMP Clearance Framework with increasing application numbers and complexity of evaluations. So there will be a focus on GMP clearance for overseas manufacturers as this is a crucial part of product registration and listing, and maintaining an ARTG entry. Learn about the key strategic objectives that continue to be delivered despite the current challenges as well as future plans to address the current backlogs.
The session will also feature a 20 minute Panel session, giving attendees the opportunity to ask questions on any areas of interest.
The Manufacturing Quality Branch, TGA has a wide range of regulatory responsibilities covering manufacturing sites, quality requirements for unapproved medicines and recall activities. This session will outline the Branch’s high priority topics and plans for the next 12 months.
The effect of the COVID-19 pandemic on global GMP inspections continues to affect the GMP Clearance Framework with increasing application numbers and complexity of evaluations. So there will be a focus on GMP clearance for overseas manufacturers as this is a crucial part of product registration and listing, and maintaining an ARTG entry. Learn about the key strategic objectives that continue to be delivered despite the current challenges as well as future plans to address the current backlogs.
The session will also feature a 20 minute Panel session, giving attendees the opportunity to ask questions on any areas of interest.
Biography
35+ years’ experience in the Pharmaceutical and Veterinary medicines industry in Australia, England and the United States.
Particular expertise in Warehousing and Distribution, Licensing (State / Territory, ODC), Medicinal Cannabis, Supply Chain complexities, Auditing, Root Cause Analysis, Risk, Statistics, Quality Systems and Commercial QA.
Implementation of Quality and business systems, improvement of processes through OEE, SPC and Six Sigma methodologies, project managed transfers, product launches, system implementations, compliance gaps, licensing (TGA, State + Territory, ODC) and been a key contributor in the inception of a global pharmaceutical affiliate office and other start-ups.
Mentor and coach in compliance, a respected trainer and presenter in multiple facets of GxP, including industry seminars.
Jenny Burnett
Assistant Secretary
TGA - Manufacturing Quality Branch
Update from the Manufacturing Quality Branch - TGA
Abstract
The Manufacturing Quality Branch, TGA has a wide range of regulatory responsibilities covering manufacturing sites, quality requirements for unapproved medicines and recall activities. This session will outline the Branch’s high priority topics and plans for the next 12 months.
The effect of the COVID-19 pandemic on global GMP inspections continues to affect the GMP Clearance Framework with increasing application numbers and complexity of evaluations. So there will be a focus on GMP clearance for overseas manufacturers as this is a crucial part of product registration and listing, and maintaining an ARTG entry. Learn about the key strategic objectives that continue to be delivered despite the current challenges as well as future plans to address the current backlogs.
The session will also feature a 20 minute Panel session, giving attendees the opportunity to ask questions on any areas of interest.
The effect of the COVID-19 pandemic on global GMP inspections continues to affect the GMP Clearance Framework with increasing application numbers and complexity of evaluations. So there will be a focus on GMP clearance for overseas manufacturers as this is a crucial part of product registration and listing, and maintaining an ARTG entry. Learn about the key strategic objectives that continue to be delivered despite the current challenges as well as future plans to address the current backlogs.
The session will also feature a 20 minute Panel session, giving attendees the opportunity to ask questions on any areas of interest.
Biography
Jenny Burnett is the Assistant Secretary of the Manufacturing Quality Branch (MQB). MQB assists in the timely supply of therapeutic goods, ensuring they are of appropriate quality for their entire lifecycle. This primarily relies on assessing manufacturers' compliance with Good Manufacturing Practices for medicines, blood, cell, and tissues products and conducting product recalls for all types of therapeutic goods.
Jenny has a science background, working as a chemist in both private industry and government laboratories. After a number of years in the Laboratories Branch of the TGA, and a stint of living overseas for 3 years, she returned to the TGA and spent time in various pre-market assessment areas in medicine regulation before moving to MQB in mid-2021. She is also the current chair of the PIC/S Subcommittee on Strategic Development.
Stephen Farrell
Director, Manufacturing Quality Clearance Section
Manufacturing Quality Branch (TGA)
Update from the Manufacturing Quality Branch - TGA - GMP Clearances
Abstract
The Manufacturing Quality Branch, TGA has a wide range of regulatory responsibilities covering manufacturing sites, quality requirements for unapproved medicines and recall activities. This session will outline the Branch’s high priority topics and plans for the next 12 months.
The effect of the COVID-19 pandemic on global GMP inspections continues to affect the GMP Clearance Framework with increasing application numbers and complexity of evaluations. So there will be a focus on GMP clearance for overseas manufacturers as this is a crucial part of product registration and listing, and maintaining an ARTG entry. Learn about the key strategic objectives that continue to be delivered despite the current challenges as well as future plans to address the current backlogs.
The session will also feature a 20 minute Panel session, giving attendees the opportunity to ask questions on any areas of interest.
The effect of the COVID-19 pandemic on global GMP inspections continues to affect the GMP Clearance Framework with increasing application numbers and complexity of evaluations. So there will be a focus on GMP clearance for overseas manufacturers as this is a crucial part of product registration and listing, and maintaining an ARTG entry. Learn about the key strategic objectives that continue to be delivered despite the current challenges as well as future plans to address the current backlogs.
The session will also feature a 20 minute Panel session, giving attendees the opportunity to ask questions on any areas of interest.
Biography
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 aseptic fill and finish operations and radiopharmaceuticals.
Stephen is also the chair of PIC/S Inspection Reliance Working Group leading efforts on increasing the use of GMP inspection reliance practices across PIC/S participating authorities.
