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Second Industry Forum on Good Manufacturing Practice - GMP²
2019 GMP Forum
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.
- 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
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.
|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|
|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|
GMP Clearance processes
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|
Looking at the future:
|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|
(*) 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
|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:
Biological GMP Inspections:
Medicine GMP Inspections:
Office of Drug Control: Regulation of medicinal cannabis
- 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.
- 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.
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.
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.