IPS - FIP Industrial Pharmacy Section Workshop – Good Manufacturing Practice (GMP)– Where are we now and what does the future look like?

M9 Saturday 23 September 2023, 09:00-17:00

Organised by FIPs Industrial Pharmacy Section (IPS)

Target audience: Industrial Pharmacists, scientists and leaders in manufacturing environments

Chair(s)

Mr Sola Solarin, President FIP Industrial Pharmacy Section, Nigeria

Introduction

Introduction:
An everchanging landscape for Good Manufacturing Practice brings us to this Workshop with IPS. Continuous advancements in pharmaceutical regulations and technology, highlights the need to improve our current skill-set as industry professionals.
The IPS GMP Workshop will attract scientific and industry professionals to gather with an intent to learn, discuss recent GMP updates and best practices, analyze successful endeavors and interrogate publicized GMP non-compliances.

What to expect:

Obtain an overview on the revised Annex 1 to the PICs/GMP.
Learn about the impact of Pharmaceutical Digital Transformation.
Critically assess where some gaps exist that cost lives – case study.
Hear about new technologies, including robotics and automation
Enjoy panel discussions and be part of robust dialogue and learnings from global colleagues
Network with peers

Programme

09:00 – 09:30	Keynote address – Where are we now, and where to from now Dr Jude Nwokike, Vice President & Director, Promoting the Quality of Medicines Plus (PQM+) Program, USP
09:30– 10:00	Revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products Mr Matt Davis, GMP lead inspector, Australian Regulator, TGA
10:00 – 10:05	Q&A
10:05 – 10:35	PIC/s Update and Managing PIC/s Inspections Mr Bob Tribe, Former Chairman of PIC/s
10:35 – 10:45	Q&A
10:45 – 11:15	Coffee/tea break & networking
11:15 – 11:45	Validation Mr Pierre Winnepenninckx, No Deviation
11:45 – 11:50	Q&A
11:50 – 12:20	Where is industry on adoption Mr Maurice Parlane, CBE Pty Ltd (Australia) and New Wayz Consulting Limited (New Zealand)
12:20 – 12:50	Panel Discussion with Mr Pierre Winnepenninckx and Mr Maurice Parlane
13:00 – 14:00	Lunch break
14:00 – 14:25	Diethylene Glycol and case study based on falsified medicines. Practical implementation of WHO requirements in an African company Mrs Tammy Chetty Gopal, IPS Exco member and Adcock Ingram South Africa
14:25 – 15:00	GMP Challenges in Developing Countries Dr Onyenoha Chukwumerije, United States
15:00 – 16:00	Innovations in factories: Science Behind Tablet Characterisation Mr Robert Sedlock, Natoli Engineering Company, Inc
16:00 – 16:30	Closing Panel Discussion: GMP of the future: Dr Jude Nwokike, Mr Robert Tribe, Dr Onyenoha Chukwumerije, Mr Robert Sedlock
16:30 – 16:45	IPS President close

Learning objectives

Understand Annex 1 to the PICs/GMP guide. Be able to develop contamination control strategies
Understand Validation in a GMP environment
Recognise trends in automation in the pharmaceutical industry
Know where GMP is headed and what role you have to play

Registration

The session is accessible with pre-registration only via the regular congress registration. Costs are $195 (incl. GST) for FIP members and students and $295 (incl. GST) for non-FIP members.