2022

2024 2023

Q1 Conference

SCHEDULE

08:30	08:30 Rathaskar Suite reception, Killashee Hotel Registration and light breakfast	Rathaskar Suite reception, Killashee Hotel
09:00 – 09:05	09:00 – 09:05 Q1 Scientific – a Cambrex company Welcome and introduction to the conference Rathaskar Suite	Rathaskar Suite
09:05 – 10:05	09:05 – 10:05 Dr. Mark Powell – Director at MP Scientific Risk-based stability studies Rathaskar Suite Quality risk management is now accepted by industry and regulators as an essential tool during the development and commercial life of a pharmaceutical product. The purpose of this presentation is to illustrate the use of quality risk management in drug product stability studies. For example, the use of accelerated stability models during early-stage development can predict real-time degradation mechanisms and kinetics, allowing the most appropriate packaging to be selected and the likely shelf life of the drug product to be estimated. Dr. Mark Powell will discuss: • Common accelerated stability models and shelf-life prediction • Current industry practice • Common degradation pathways for chemical drugs • Common degradation pathways for biologics • Risk-based stability study design Followed by a Q&A session with Dr. Mark Powell	Rathaskar Suite
10:05 – 11:05	10:05 – 11:05 Ken O’Shea – Managing Director and Owner at QbD Pharma Solutions Lean product development in Pharma Rathaskar Suite Lean thinking and Six Sigma have been employed by manufacturing companies to reduce costs, increase productivity, and improve quality by reducing process variation and production defects. In more recent times these tools have been used in the pharmaceutical industry, with companies implementing Lean to accomplish such goals as accelerated product development, improved time to market, reduced production waste, and higher levels of quality in both production and testing. Chemistry, manufacturing, and controls (CMC) are crucial activities when developing new pharmaceutical products. When applied to CMC, Lean product development holds the promise of dramatically improving a company’s competitive position. Its implementation offers the potential for faster product development with fewer development hours, improved manufacturability of products, higher quality products, fewer production start-up problems, and faster time to market, all of which improve the potential for market success post launch. During this presentation Ken O’Shea will discuss: • Common QbD principles as they are applied in CMC • How Lean principles can be employed to improve pharmaceutical development and CMC • The concept of Lean Stability and the potential for its application in regulated environments Followed by a Q&A session with Ken O’Shea	Rathaskar Suite
11:05	11:05 Break area Morning break with tea and coffee	Break area
11:30 – 12:15	11:30 – 12:15 Stephen Delaney – Managing Director at Q1 Scientific Stability storage and monitoring tips Rathaskar Suite • Inventory management • Handling of stability chambers • Impact assessments of temperature and humidity excursions • Chamber backup strategies • Decreasing overheads Followed by a Q&A session with Stephen Delaney	Rathaskar Suite
12:15 – 13:15	12:15 – 13:15 Dr. Rebecca Yip Ghosh – Project Scientist 3 at Cambrex Stability studies within solid form screening Rathaskar Suite • Solid form screening at Cambrex • Difference between Chemical vs Physical stability • Consideration of stability in development of chosen solid forms • Pre-clinical formulation and stability considerations Followed by a Q&A session with Dr. Rebecca Yip Ghosh	Rathaskar Suite
13:15 – 13:30	13:15 – 13:30 Rathaskar Suite Closing remarks from Q1 Scientific	Rathaskar Suite
13:30	13:30 Break area Lunch and networking	Break area