Inaugural Industry Forum on Good Manufacturing Practice (GMP)

2018 GMP Forum

12 April 2018

Registrations NOW Open

On 7 March 2018, the Therapeutic Goods Administration (TGA) announced that it will be hosting the inaugural 2018 GMP Forum in conjunction with the RACI, ARCS, PDA and ISPE[1].

Forum details

  • When: Tuesday, 26 June 2018
  • Time: 8:30am – 5:00pm AEST
  • Where: SMC Conference & Function Centre, 66 Goulburn Street, Sydney NSW 2000

The Forum is supported by members of the TGA-Industry Working Group on GMP (TIWGG) whose membership comprises representatives from numerous peak industry associations and industry personnel nominated by those associations.

Registration

Registrations for the 2018 GMP Forum are now open until Friday, 8 June 2018. Delegates are encouraged to register as soon as possible as late registrations after 8 June will incur a significant surcharge.

Delegates are requested to download and complete the registration form and submit it to GMPForum2018@health.gov.au for processing. An invoice and payment instructions will then be provided and delegates' attendance confirmed as soon as the payment is processed.

Event registration is inclusive of GST, morning tea, lunch and afternoon tea; and access to all sessions. Any specific dietary requirements or requests should be advised on the registration form.

How to access a pdf or Worddocument

Who should attend

The Forum will be of significant interest to industry personnel involved in the quality assurance, regulation, risk assessment and good manufacturing practice of medicines, in addition to personnel working for medicine-based small and medium enterprises (SMEs).

In particular, the Forum will be relevant to the work of industry personnel employed by sponsors and manufacturers of prescription, over-the-counter and complementary medicines; Active Pharmaceutical Ingredient (API) manufacturers; as well as regulatory consultants who work within the therapeutic goods industry.

Small and medium enterprises (SMEs)

In June 2017, the "SME Assist" program was launched. The SME Assist hub is designed to help small and medium enterprises; and R&D groups developing new medicines and medical devices (including apps) understand their regulatory and legislative obligations with targeted tools and content.

The Forum program includes sessions which will also be of direct interest to medicine based SMEs and cover introductory topics including those relating to medicine manufacturing and GMP Clearance requirements.

Program overview

The proposed program is now available and features a range of senior TGA speakers who are subject matters experts in the manufacture and regulation of medicines. During plenary, interactive and concurrent sessions, they will discuss a range of interesting and innovative topics covering different aspects of medicinal Good Manufacturing Practice.

Program highlights include:

  • Overview of the TGA's involvement in the international regulatory environment
  • GMP Clearance updates
  • Adoption of, and transition to the new PIC/S GMP Guide PE009-13
  • GMP Obligations for Small and Medium Enterprises (SMEs)
  • SME Education
  • GMP inspection requirements.

Further enquiries

For further enquiries, please contact Ms Karen Sivonen, Manufacturing Quality Branch:

Proposed program

Print version of proposed program (pdf,108kb)

Time Topic Speaker Room
8:30am Registration Marble Foyer
9:00am Welcome Ben Noyen – Assistant Secretary, Manufacturing Quality Branch (MQB) Grand Lodge
9:10am Introductory remarks Adjunct Professor John Skerritt – Deputy Secretary, Health Products Regulation Group (HPRG)
9:20am TGA Fees & Charges Ben Noyen
9:40am Overview of TGA's involvement in the International Regulatory Environment Jenny Hantzinikolas – Director, Inspections Section (IS), MQB
10:10am

GMP Clearance updates - MRA and CV processes

  • Changes
  • Improvements
  • Challenges
Stephen Farrell – Assistant Director, Licensing & Certification Section (LCS), MQB
10:30am MORNING TEA Marble Foyer
11:00am Driving a GMP culture to provide supporting evidence of better business outcomes Robert Caunce – Senior GMP Inspector, IS Grand Lodge
11.45am

Adoption of PIC/S GMP Guide PE009-13

  • MQB Strategy
  • Timeframes
  • Transitional arrangements

Matt Davis - Senior GMP Inspector, IS

Neale Baldwin – Team Leader & Senior GMP Inspector, IS

12:30pm LUNCH Marble Foyer
CONCURRENT SESSIONS
(*) For the following sessions, specific details for the listed topics and the allocated speakers are subject to further refinement and change. A final program will be published in early June.
Expectations with Adoption of the PIC/S GMP Guide PE009-13
1:30pm
  • Chapter 1 – Pharmaceutical Quality System
  • Chapter 7 – Outsourced Activities
  • Annex 1 – Feedback on Draft
  • Annex 15 – Qualification and Validation
  • Other specific expectations

Matt Davis

Neale Baldwin

David Rowbury - Senior GMP Inspector, IS

Emmett Broderick - GMP Inspector, IS

Grand Lodge
GMP Obligations for Small and Medium Enterprises (SMEs)
1:30pm
  • Overview of the SME Assist program
Avi Rebera – Assistant Secretary, Regulatory Engagement and Planning Branch (REPB) Ionic Room
1:50pm
  • Manufacturing Basics
Greg Orders - Senior GMP Inspector, IS
2:30pm
  • GMP Clearance Processes

Stephen Farrell

Darika Sowana - Assistant Director, LCS

3:10pm
  • Recalls
Craig Davies - Director, Recalls and Case Management Section, MQB
3:30pm AFTERNOON TEA Marble Foyer
CONCURRENT 'STAND–UP' SESSIONS
Group A topics - GMP inspection requirements
4:00pm 1. Risk based approach to inspection frequency, re-inspection frequency & different product types, including APIs

Doreene Kohalmi
Senior GMP Inspector, IS

Grand Lodge
2. Emerging trends & developments, common inspection deficiencies and other concerns Jenny Hantzinikolas
Group B topics – SME Education
4:00pm 1. GMP Clearance processes – common mistakes and TGA code tables

Stephen Farrell

Darika Sowana

Grand Lodge
2. NEW Uniform Recall Procedure for Therapeutic Goods Craig Davies
4:50pm Concluding remarks Ben Noyen Grand Lodge
5:00pm Meeting close

Footnotes

  1. RACI - Royal Australian Chemical Institute
    ARCS - Association of Regulatory and Clinical Scientists to the Australian Pharmaceutical Industry
    PDA - Parenteral Drug Association Australia Chapter
    ISPE - International Society for Pharmaceutical Engineering