Stability Studies Conference 2022

Join us to learn all about managing and evaluating stability studies across the product life cycle efficiently while meeting regulatory requirements

Killashee Hotel, Naas, Co. Kildare, Ireland
Thursday 13th October 2022

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Stability Studies

Conference 2022

How do you approach different aspects of managing and evaluating stability studies across the product life cycle efficiently while meeting regulatory requirements?

Stability testing plays an important role throughout the product lifecycle, impacting the development of products, regulatory clearance, post-market quality assurance and regulatory reporting for approved products.

Regulatory Pressures


With pharmaceutical and medical device companies under increased pressure to meet regulatory requirements while decreasing margins and avoiding product recalls the impact of stability studies on product development and commercialisation has never been greater.

Join us at the Killashee Hotel on Thursday 13th October 2022, to hear analytical and quality professionals from the European pharmaceutical industry discuss their experiences around managing and evaluating stability studies:

 

  • In early-stage preclinical development
  • During clinical studies
  • In late-stage development for regulatory filing
  • Post-approval

This conference is aimed at:

  • Stability Programme Managers and Staff
  • Research & Product Development Scientists and Managers
  • Analytical Chemists and Microbiologists
  • QC/QA Professionals
  • Qualified Persons (EU)
  • Regulatory Affairs professionals
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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

Conference 2022

Speakers

Dr. Mark Powell

Dr. Mark Powell

Director at MP Scientific
Ken O'Shea

Ken O’Shea

Managing Director and Owner of QbD Pharma Solutions
Stephen Delaney

Stephen Delaney

Managing Director at Q1 Scientific – a Cambrex company
Dr. Rebecca Yip Ghosh

Dr. Rebecca Yip Ghosh

Project Scientist 3 at Cambrex

Venue

Killashee Hotel

Killashee Hotel is located 30km from Dublin city centre, 2km outside of Naas Town and only 40 minutes from Dublin airport.

Use the map to get directions from your location.

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Get In Touch

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Westside Business Park,
Old Kilmeaden Road,
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