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Second Industry Forum on Good Manufacturing Practice - GMP²

2019 GMP Forum

18 November 2019
GMP 2019 logo

The Therapeutic Goods Administration (TGA), in conjunction with the RACI, ARCS, PDA and ISPE, invites you to attend the second annual Good Manufacturing Practice (GMP) Forum, GMP2.

The Forum provides an opportunity to learn about good manufacturing practice relating to prescription, over-the-counter and complementary medicines.

Forum details

  • Date: Thursday, 21 November 2019
  • Time: 8:00am - 6:00pm AEDT
  • Location: The Pullman Melbourne Albert Park (the Pullman), 65 Queens Road, Melbourne, Victoria 3004.
  • Registration: REGISTRATION NOW CLOSED

Program

The program and speakers for the 2nd GMP Forum are now available with the following topics featured:

  • Common inspection deficiencies and emerging issues
  • Computerised systems - trends observed at inspections
  • Medicinal cannabis - an overview of GMP requirements
  • "A day in the life of a GMP inspector"
  • PIC/S Guide to GMP
    • Version 13 chapter and annexe overviews
    • The future: Version 14 and beyond
  • GMP Clearance:
    • Where we are now, future direction and focus
    • GMP Agreements and PIC/S Guide to GMP
    • Answers to industry's most frequently asked questions
    • GMP Clearance for Prescription medicines
  • New and emerging technologies

Speakers will include senior officials and subject matter experts from both the TGA and medicines industry. The program will be delivered through a mix of formal presentations, interactive sessions and thought provoking panel discussions.

At this year's event, we will also have a dedicated 'Meet the TGA' break-out area. This will allow delegates to informally meet with some of the TGA's GMP inspectors and specialised staff from other business areas throughout the day.

Print version of draft program (pdf,187kb)

Program

Some topics and speakers may be subject to change and confirmation

Time Topic Speaker Room
8:00am Registration, welcome tea and coffee Grand Ballroom Lobby
1st Plenary Session Session Chair: Ben Noyen - Assistant Secretary, Manufacturing Quality Branch (MQB) Grand Ballroom 1-4
8:45am Welcome and opening remarks Ben Noyen Grand Ballroom 1-4
9:00am Keynote address Adjunct Professor John Skerritt - Deputy Secretary, Health Products Regulation Group Grand Ballroom 1-4
9:30am Building a GMP compliant culture - an industry perspective Mark Koen - Head of Commercial Quality, Boehringer-Ingelheim Pty Ltd Grand Ballroom 1-4
10:00am Common inspection deficiencies and emerging areas Jeff Wan - GMP Inspector Grand Ballroom 1-4
10:30am MORNING TEA Grand Ballroom Lobby
10:30am-3:45pm "Meet the professional societies" and "Visit the TGA" Grand Ballroom 6
CONCURRENT SESSIONS
1st Concurrent Session Session Chair: Jenny Hantzinikolas - Director, Inspections Section, MQB Grand Ballroom 1-4
11:00am Data Integrity in the Laboratory Gaye Camm & Matt Davis - Senior GMP Inspectors
12:15pm ISO TC 198 Sterilization of health care products - revising and modernising aseptic processing standards to reflect best practice Karen Longstaff - Chief Microbiologist - Microbiology Section
1st Concurrent Session Session Chair: Craig Davies - Director, Recalls Section, MQB Grand Ballroom 5
11:00am

GMP Clearance processes

  • Where we are now
  • Future direction and focus
  • GMP Agreements and the PIC/S GMP Guide
  • Answers to industry's most frequently asked questions
  • When is a GMP Clearance required for listed, over-the-counter and prescription medicines

Stephen Farrell - Acting Director, GMP Clearance Section

Darika Sowana - Assistant Director, GMP Clearance Section

12:45pm LUNCH Grand Ballroom Lobby
2nd Concurrent Session Session Chair: Jenny Hantzinikolas Grand Ballroom 1-4
1:45pm Medicinal cannabis: an overview of the GMP requirements Maurice Makdessi - Senior GMP Inspector
2:15pm

Looking at the future:

  • PIC/S GMP Guide Version 14 and beyond
  • overview of the adoption process and the changes
Neale Baldwin & Matt Davis - Senior GMP Inspectors
2:45pm Testing Program for TGA Laboratories' Chemistry Section Bill Sherwin - Director, Chemistry Section
2nd Concurrent Session Session Chair: Craig Davies Grand Ballroom 5
1:45pm GMP for new and emerging technologies: Faecal Microbiota Transplantation (FMT) Alyce Maksoud - Senior GMP Inspector
2:15pm GMP for new and emerging technologies: Advanced Therapy Medicinal Products (ATMPs) Francesco Cicirello - GMP Inspector
2:45pm Pharma 4.0 Practical Implementation Tools Trevor Schoerie - Managing Director, Pharmout
3:15pm AFTERNOON TEA Grand Ballroom Lobby
2nd Plenary Session Session Chair: Ben Noyen Grand Ballroom 1-4
3:45pm How to be successful at inspection? Jenny Hantzinikolas, Neale Baldwin, Alyce Maksoud, Greg Orders, Katherine Clark
4:50pm Concluding remarks Ben Noyen
5:00pm Cocktail Hour Pullman Hotel - Main Lobby
6:00pm Forum close

(*) Some topics and speakers may be subject to change and confirmation

Networking and Q&A opportunities

As part of the 2019 GMP Forum, delegates will be able to "Meet the professional societies" and "Visit the TGA" during session breaks and throughout the day at a 'café style' area within the designated conference venue - Grand Ballroom 6.

This area will be open from 10:30am-3:45pm and will be staffed by TGA officers from a selected range of business areas and professional society representatives. This presents a unique opportunity for delegates to discuss issues of direct interest and relevance to them with the TGA and various professional societies in smaller group or one-on-one settings, as time permits.

"Meet the professional societies"

Representatives from the following professional societies will be in attendance at the 2019 GMP Forum:

  • 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
Time Topic
10:30am-3:45pm Meet with representatives from RACI, ARCS, PDA and ISPE to learn more about the roles of the organisations, the services they offer, events they host and membership opportunities.

"Visit the TGA"

Delegates will also be able to raise questions with TGA officers about various aspects and legislative requirements relating to Good Manufacturing Practice (GMP) and the broader Australian therapeutic goods regulatory framework.

A number of breakout areas will be staffed as follows:

Time Topic
10:30am-12:45pm

Biological GMP Inspections:

  • Australian Code of GMP
10:30am-3:45pm

Medicine recalls:

  • Is my product unsafe or defective?
  • How do I know and what do I do?
  • How do I conduct an effective recall?
  • Recent and proposed changes to the Uniform Recall Procedure for Therapeutic Goods (URPTG)
  • Demonstration of the NEW online 'recall notification' e-form
10:30am-3:45pm

Medicine GMP Inspections:

  • PIC/S Guide to GMP – Chapters and Annexes
10:30am-3:45pm

SME Assist:

  • GMP Obligations for Small and Medium Enterprises (SMEs)
  • Overview of the SME Assist program
10:30am-3:45pm

Office of Drug Control: Regulation of medicinal cannabis

  • Import and export
  • Acquiring stock and cultivation
  • Manufacture and supply
  • Licences and permits
  • Patient access
12:45pm-3:45pm

GMP Clearances:

  • the desk top / clearance framework
  • MRA vs CV pathways
  • submitting effective GMP Clearance applications
  • recent business process improvements
  • industry education initiatives

Important notes

  1. As a large number of delegates are expected to attend the 2019 GMP Forum, it is likely that representatives at each of the breakout areas will need to apply time limits to the amount of time available to answer various questions.
  2. The responses will be general information that will be given without prejudice; is not binding on the TGA and delegates should get their own independent legal advice to ensure that any directly applicable legislative requirements are met.

Accommodation

Pullman Melbourne Albert Park offers the following conference rate for GMP Forum guests staying 20 and/or 21 November 2019.

Pullman Guest room: $250.00 per room per night, including:

  • one full hot buffet breakfast served in the Windows Restaurant
  • complimentary WiFi

Additional breakfasts may be added at the time of booking for $25.00 per person.

To secure the conference rate, bookings must be made by phone directly with the Pullman's Reservations on 03 8554 2528, quoting the "Department of Health/TGA Conference".

It is recommended that delegates book accommodation as early as possible as Melbourne will also be hosting a major international event at this time.

Further information, including a first draft of the Forum program will soon be published.

'Meeting your obligations' workshop

In addition to the GMP Forum, SME Assist will be presenting a 'Meeting your obligations' workshop in Melbourne on the preceding day, Wednesday, 20 November 2019 from 1.00pm - 4.30pm. Further details are available at 'Meeting your obligations' workshop Melbourne.

Further enquiries

For further enquiries, please contact Ms Karen Sivonen, Manufacturing Quality Branch on 02 6221 6831 (tel), 02 02 6203 1451 (fax) or by email GMPForum2019@health.gov.au.