Quality Risk Management (ICH Q9): Advanced Practical Applications
4:00 PM – 5:30 PM, Central European Time (CET)
10:00 AM – 11:30 AM, Eastern Time (ET)
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Overview
Effective risk management is paramount in the dynamic pharmaceutical landscape. The ICH Q9 (R1) framework provides a comprehensive guide on targeting, assessing, and treating operational risks.
Join our exclusive webinar to explore the depths of ICH Q9 and elevate your understanding of pharmaceutical risk management.
- Engage with case studies and a practical example for hands-on learning.
- Participate in lively Q&A sessions and discussions to gain insights from industry experts.
- Delve into a fascinating example from Radiopharma, focusing on GMP and safety.
- Learn to apply the ICH Q9 risk model across various applications.
By the end of the webinar, you will be equipped with practical knowledge, real-life examples, and actionable advice to streamline your pharmaceutical risk management processes.
Don’t miss this opportunity to revolutionize your approach to risk management in the pharmaceutical industry! Join us and embark on a journey towards excellence.
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Who Should Attend:
- Quality assurance employees
- Quality managers
- Regulatory managers
- Quality directors
- Skill Level: Novice, Intermediate , Expert
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Topics:
- Understand and apply the key elements of ICH Q9 (R1) pharmaceutical risk management
- Learn how to apply the ICH Q9 risk model to your business, from communication and assessment to control and review
- Access a range of tools, guidelines and best practice frameworks to make risk management a natural part of your product lifecycle
Speakers
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Paul PalmerManaging Director at Pharma Quality Services LTDPaul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU /UK Qualified Person since 2004. He has over 36 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices. Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerized systems, as well as the facilities and services to support each.
Qualified as a Lead auditor, Paul has been auditing suppliers and internal management systems since 1998 and still remembers the advice of his manger Robert Whitham on his first solo audit. Remember not everyone does GMP the same way, just because they don’t do it the same way as us doesn’t mean its wrong. Seeing new ways and applying the knowledge to other fields or companies allows Paul to think laterally often developing a creative solution no one else considered.
People and systems have always been a core focus, how to ensure best use, optimize and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Educationally Paul has a Degree in Applied Biology, an MSc in Quality Management, a Post Graduate Diploma in Pharmaceutical Studies and an EMBa in Business administration all of which bring more depth to his experience and knowledge -
David CroninChief Business Officer at Biotech Cognition CorporationDavid has worked for over 30 years in the life sciences industry, with the last 20 years improving IT data science models that combine internally structured data items, connections, and deliverables for pharmaceutical and medical device submissions. David brings a knowledge of structured content & data management with industry standards and regulations to improve data integrity and chain of custody for complex reports and traces in product development and commercialization. David also serves as the Co-Chair for the International Council On Systems Engineering (INCOSE) Healthcare Working Group.
David holds a Bachelor or Science degree in Electrical Engineering and an MBA, both from Northeastern University in Boston, MA. David lives in Cape Cod, MA with his wife Laureen. When not working, David can be found in his gardens among the plants and Koi, or fly fishing the ocean waters of Cape Cod, Massachusetts.
Partner
Qualio
Website
https://qualio.com/Founded in 2012, Qualio is the first cloud quality management software for all Life Sciences companies. Medical device and pharmaceutical companies need a secure and scalable quality management system with the flexibility to support their evolving needs. Qualio meets that challenge by cutting through the complexity to optimize and automate critical quality processes. The remote-first, Qualio team is distributed across North America and Europe.
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