Taking risks: ICH Q9 (R1) Quality Risk Management
4:00 PM – 5:30 PM, Central European Time (CET)
10:00 AM – 11:30 AM, Eastern Time (ET)
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Overview
ICH Q9 (R1) outlines the fundamentals of how pharmaceutical businesses should target, assess, and treat their operational risks.
Our deep-dive ICH Q9 webinar arms our viewers with everything they need for world-class pharma risk management – from embedding all the ingredients of the ICH Q9 process to making a risk-based approach natural and automatic.
At the webinar, you will:
– 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.
The webinar will provide great value for Quality Assurance employees, Quality Managers, Regulatory Managers, Quality Directors.
Don’t miss this exclusive opportunity to register now!
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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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Charley MaxwellManaging Director & Consultant QP / RPCharley is the owner and Managing Director of Orion GXP Consulting. He has over 20 years of experience working in manufacturing QA, regulatory compliance, batch release, and distribution in the pharmaceutical and medical device industry. He has assisted multiple clients with designing, developing, and implementing phase-appropriate Quality Management Systems, vendor management, audit programs, quality risk management, and training. Charley has a Bachelor’s of Science In Biochemistry and a Master’s In Pharmaceutical Manufacturing Technology. He has acted as a QP in Ireland for sterile and non-sterile manufacture, clinical IMP release, and third-country Importation.
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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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