2023 GMP Forum
Selected Presentations from the PharmOut GMP Forum 2023
Not all presentations from the GMP Forum 2023 are able to be shared. Below are those where permission has been granted by the speaker.
Day 1
Plenary
Presentation Summary
- Technological Disruption: The presentation discusses the ongoing technological disruption, mentioning platforms like Chegg, Co-pilot, Syntex, Viva Sales, MS Designer, and ChatGPT. It also mentions the use of deepfake and text-to-voice technologies. The presentation highlights the speed at which these disruptions are happening. (Page 5)
- Mega Trends in 2023: The presentation outlines several mega trends for 2023, including technological advancement (AI, automation, robotics, IoT, blockchain, VR, biotechnology), demographic shifts (aging population, urbanization, global migration patterns), sustainability and environmental concerns, globalization and economic interconnectivity, changing work patterns (automation, gig economy, remote work, workforce diversity), and health and wellness (preventive healthcare, personalized medicine, digital health technologies). (Page 4)
- IoT Gadgets: The presentation mentions IoT gadgets, specifically referencing fall sensors from Texas Instruments and the concept of “Age in Place”. (Page 1)
Presentation Summary
- Common Excuses: The presentation starts by listing common excuses often used in corporate settings, such as “I have no recollection,” “I wasn’t at that meeting,” “I acted on advice given,” etc. It also mentions several companies like Amazon, Boeing, Deloitte, Ericsson, Ernst & Young, KPMG, Mylan, Purdue, RSM, Takata, Turing, Valeant, Wells Fargo, and WeWork. (Page 3)
- Decision Making: The presentation discusses different approaches to decision-making, contrasting instinctive decision-making with a more thoughtful, risk-assessment approach. (Page 0)
- Problem Solving: The presentation includes a quote about problem-solving, emphasizing the importance of not making things worse by guessing and the value of a fresh team in thinking clearer. (Page 7)
- Challenges to Critical Thinking: The presentation outlines several reasons why people might struggle with critical thinking, including lack of time, snap judgments, biases, feelings trumping facts, and the demand for immediate profits. (Page 12)
Presentation Summary
- Bacterial Endotoxins Test & Alternative Methods using Recombinant Protein-reagents for Endotoxin Assay: This presentation discusses the harmonized bacterial endotoxins test and alternative methods using recombinant protein-reagents for endotoxin assay. It provides an update on the regulatory status of these methods in different pharmacopeias, including the US, EU, JP, CH, and others. The use of recombinant factor C (rFC) is highlighted in these updates. (Page 22)
- Alternative Validation for rFC Setup and Performance: The presentation outlines the process for alternative validation for rFC setup and performance, including method validation, non-interfering concentration testing, and testing for interfering factors. (Page 23)
- Published Findings on rFC and LAL: The presentation references over 30 peer-reviewed publications that have found rFC and LAL to be equivalent and comparable. It also states that rFC is superior to LAL in terms of endotoxin specificity, reproducibility, and consistency. (Page 20)
- BET Challenges: The presentation identifies several challenges associated with Bacterial Endotoxins Test (BET), including the cost of reagents and equipment, sample throughput, matrix interference, required training/skills, support from the vendor, regulations, and validation. (Page 3)
Presentation Summary
- Clinical Trial Regulations: The presentation discusses clinical trial regulations, providing information on the Clinical Trial Approval Scheme (CTA) and the Clinical Trial Notification Scheme (CTN). (Slide 6, 7)
- Principles of Good Clinical Practice (GCP): The presentation outlines the principles of GCP, including medical care and decision-making by medics, competent personnel, freely given informed consent, trial data recording, storage, analysis, and reporting, privacy and confidentiality, investigational products to applicable GMP, and quality management systems. (Slide 5)
- Review Process: The presentation describes the review process for clinical trials, including registration, application creation, question submission, review outcome, and final decision. It mentions that the average turnaround time for the whole process is 21 days, with submission to review taking 16 days. (Slide 13)
- Contact Information: The presentation provides contact information for further queries, including websites (www.tga.gov.au, www.australianclinicaltrials.gov.au, www.bellberry.com.au) and email address ([email protected]). (Slide 15)
Presentation Summary
- Global Health Impact: The document discusses the results and impact of certain initiatives on global health. It emphasizes the need for collaboration, scaling up efforts, and urgency in addressing global health issues. (Source: PDF Page 1)
- Pharmaceuticals and Global Health: The document explores the impact of pharmaceuticals on global health. It highlights the role of the Pfizer/BioNTech Covid-19 vaccine, with Margaret Keenan being the first person in the UK to receive it. (Source: PDF Pages 5 and 6)
- COVID-19 and the SDGs: The document discusses the impact of the COVID-19 pandemic on Global Health and the Sustainable Development Goals (SDGs).
- Polycrisis: The document introduces the concept of a “polycrisis” and its global implications. (Source: PDF Page 8)
- Call to Action: The document calls for innovation, investment, urgency, collaboration, partnering for impact, generosity, scaling up, imagination, hope, and solutions to address the current global health challenges. (Source: PDF Page 9)
- Partnership Model: The document provides a glimpse into the partnership model of ‘Results’, a global health organization.
Tracks 1,2,3
- Australian PV requirements – Carl Bufe, Director of Pharmacovigilance, PharmOut
- Contamination Control Strategy – Ashley Isbel, GMP Services Director, PharmOut
- Annex 1 – Focus on Filter Integrity Testing and PUPSIT – Micheal Schafferius, Application Specialist, Sartorius
- Smoke Visualization Studies – Seamus Orr, Technical Services Manager, AstraZeneca
- Data Integrity & Analytical Instrument Qualification – Leveraging on Supplier’s Capabilities – Sheng Sheng Su, Anton Paar
- Protecting and Defending your Intellectual Property – Mitchell Zadow, Managing Principal & Accredited Specialist (Commercial Law), Sharrock Pitman Legal | Caroline Callegari, Special Counsel, Sharrock Pitman Legal
- Real time Microbial Monitoring Progress – BioTrak – Shaun Raebel, Sales Engineer, Continuous Monitoring Systems, Contamination Control & Critical Environments, Kenelec Scientific
- Facility Design Case Study – Nic van der Nol, Director Architecture & Engineering Services, PharmOut | Faiz Ferdosian, Managing Director, Artisan Chemist
- IT / OT Megatrends in a Pharma4.0 World – Trevor Schoerie, Managing Director, PharmOut
- Review of current Australian and ISO Standards that have recently been published, and are currently under review – Paul Morgan, Critical Scientific Solutions
- Registration of Medicines – Natalie Allen, Director of Regulatory Services, PharmOut
Day 2
Tracks 1,2,3
- AI/ML Empowered Pharma4.0 Use Cases – Jonathan Krieger, Solutions Consultant Industrial Software, Emerson
- HPLC with Post Column Derivatisation: Is there any need to Panic? – Andrew Jones, Analytical Development Manager, Chemika
- Utilising Modern Methods for your Contamination Control Strategy – Tara Cassidy, NGS Account Manager, Charles River Laboratories
- Quality in Emerging Oral Therapies – Priscilla Thiyageas, Director of Quality, IDT Australia
- Operational Excellence in a Low Bioburden Biotechnology Facility – Annette Grundy, Head of Operational Excellence (PPI) Pharma Services, Thermo Fisher Scientific
- “Bringing Order to Data” in Life Sciences – Makarand (Mak) Mujumdar, Industry Specialist – Life Sciences, Australia & New Zealand, Emerson Automation Solutions
- ICHQ9 (R1) Updates – Maria Mylonas, Business Development Director, PharmOut
- Sustainability in the Cleanroom World – Shaun Raebel, Sales Engineer, Continuous Monitoring Systems, Contamination Control & Critical Environments, Kenelec Scientific
- Can Virtual Reality training have a role in GMP? – Gerry McKiernan, Director Of Quality, Cell Therapies | Jonathan Bannister, Managing Director, The Design Technology Company
- An Introduction to Clinical Trials for Pharma Professionals – Silvana Sekuloski, Lead Consultant, PharmOut
- Tulip Applications in GMP Manufacturing – Luke Armstrong, Product Quality Advisor, AstraZeneca Australia
- Continuous Improvement – How to Prove Effective Implementation – Tina Christensen-Ram, Product, Snr. Consultant, PharmOut
- Bioprocessing: Saving Lives, Feeding the World – Imko Gaastra, Area Manager Project Sales, Getinge
- We All Know What GMP is an Acronym for, or do we? – Robert Caunce, Technical Manager, Baxter Laboratories
- Selecting Software Vendors for Successful Relationships – Matthew Schoerie, QikSolve
- Tips and Tools for a Successful Root Cause Analysis (RCA) and Investigation – Mir Ali, Quality Manager, Rationale Cosmetics
- Good Distribution Practice (GDP)/ Good Warehousing Practice (GWP) – Insights into Local vs Global expectations – Sarah Ballantyne, Quality Systems Manager, Linfox Healthcare Logistics
- Stage 3 Validation – Ongoing Process Verification – Ashley Isbel, GMP Services Director, PharmOut
- A Practical Crash Course in Risk Assessments – Shane Bourne, Lead Consultant, PharmOut | Susan Cheong, Senior Consultant, PharmOut
- ICH Q13 Continuous Manufacturing of Drugs Substances and Products and Flow Chemistry – Trevor Schoerie, Managing Director, PharmOut
- The Good, the Bad and the Findings – Inspection Deficiencies and Trends – Maria Mylonas, Business Development Director, PharmOut
