Inaugural Industry Forum on Good Manufacturing Practice (GMP)

2018 GMP Forum

22 June 2018

Registrations now closed

Due to significant interest, this event is now FULLY subscribed as the venue's capacity has been reached.

No further registrations can be accepted and registration on the day will NOT be available.

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: 8:15am - 6:00pm 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 closed as the event is fully subscribed.

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

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 Final 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 and concurrent sessions, they will discuss a range of interesting and innovative topics covering different aspects of medicinal Good Manufacturing Practice.

Program highlights include:

  • Keynote address
  • 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:

Final program

Print version of final program (pdf,115kb)

Time Topic Speaker Room
8:15am Registration Marble Foyer
8:30am Welcome tea and coffee
9:00am Welcome and introductory remarks Ben Noyen - Assistant Secretary, Manufacturing Quality Branch (MQB) Grand Lodge
9:05am Keynote address Adjunct Professor John Skerritt - Deputy Secretary, Health Products Regulation Group (HPRG)
9:25am Overview of TGA's involvement in the International Regulatory Environment Jenny Hantzinikolas - Director, Inspections Section (IS), MQB
9:50am TGA Fees & Charges Ben Noyen
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 Updating Manufacturing Principles: PIC/S GMP Guide PE009-13 implementation and future updates Matt Davis - Senior GMP Inspector, IS
12:30pm LUNCH Marble Foyer or Doric Room
CONCURRENT PRESENTATION SESSIONS
1:30pm Expectations with Adoption of the PIC/S GMP Guide PE009-13 Session chair – Matt Davis Grand Lodge
 
  • Chapter 1 & 2 - Pharmaceutical Quality System & Personnel:

    PQS Clarifications, QMR requirements and Supply Chain, Quality Policy, QA/QC added responsibilities, consultant requirements

Neale Baldwin - Team Leader & Senior GMP Inspector, IS
2:00pm
  • Annex 15 - Qualification and Validation
Robert Caunce
2:30pm
  • Chapter 4 & 6 – Documentation & Quality Control:

    Retention of documents, expectations for instructions & records, clarification on required procedures, QC Trending of CQA's, clarification for reagents, reference standards, microbial reagents/media

Maurice Makdessi Senior GMP Inspector, IS
2:40pm
  • Chapter 7 - Outsourced Activities:

    etailed clarification/scope of outsourced activities

Emmett Broderick - GMP Inspector, IS
2:50pm
  • Annex 2 - Manufacture of biological medicinal substances and products for human use & Annex 11 - Computerised systems:

    Biological Medicinal requirements. Computerised system clarifications

Francesco Cicirello - GMP Inspector, IS

All

3:05pm
  • Questions
All
1:30pm GMP Obligations for Small and Medium Enterprises (SMEs) Session Chair - Craig Davies - Director, Recalls Section, MQB Ionic Room
 
  • Overview of the SME Assist program
Tahli Fenner - Acting Director, Regulatory Guidance and SME Support Section
1:50pm
  • Therapeutic Goods regulation and the GMP inspection process: An inspector's perspective
Greg Orders - Senior GMP Inspector, IS
2:30pm
  • Understanding your supply chain (GMP agreements for GMP Clearance)

Stephen Farrell

Darika Sowana - Assistant Director, GMP Clearance Section, MQB

3:10pm
  • Recalls
Craig Davies
3:30pm AFTERNOON TEA Marble Foyer or Doric Room
4:00pm CONCURRENT INTERACTIVE SESSIONS
The following concurrent sessions are intended to be interactive. For each topic listed below, the nominated presenter will speak for 5-10 minutes and the remainder of each 25 minute topic will be available for delegate participation by way of commentary and Q&A.
GMP inspection requirements Session Chair – Jenny Hantzinikolas / Neale Baldwin Grand Lodge
4:00pm
  • Risk based approach to inspection frequency, re-inspection frequency & different product types, including APIs
Doreene Kohalmi - Senior GMP Inspector, IS
4:25pm
  • Emerging trends & developments, common inspection deficiencies and other concerns
Jenny Hantzinikolas
SME Education Session Chair – Craig Davies Ionic Room
4:00pm
  • GMP Clearance processes - common mistakes made with applications

Stephen Farrell

Darika Sowana

4:25pm
  • Uniform Recall Procedure for Therapeutic Goods - application and case studies
Michael Wholley - Assistant Director, Recalls Section, MQB
4:50pm Concluding remarks

Ben Noyen

Grand Lodge
Craig Davies Ionic Room
5:00pm Meeting close
5:00 - 6:00pm Complimentary drinks Marble Foyer