Mastering Risks and Opportunities in GxP: Tips, Tools & Techniques
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Overview
Risk lurks in every corner for pharma, food, and medical device manufacturing. Organizations with solid Quality Units that understand and tackle threats usually move ahead of others.
There are many different ways to identify, review, manage, tackle risk, and harness the opportunities connected.
Join this webinar for actionable takeaways to strengthen your risk and opportunity management, from grasping the fundamentals to building a risk-based culture of continuous quality improvement.
At this webinar, Kelly Stanton, Director of Quality at Qualio, is joined by Pierre Servan, founder of Factor Quality, to discuss their hands-on experience in risk management management, and pass on insights to you.
You will learn about:
- Tips, tools, and techniques for managing risks
- Why risk-based thinking is a powerful business driver
- Standard risk management mistakes to dodge
- How to build a risk management framework that connects and involves your colleague
By the end of the webinar, you will gain new insights into how to make your organization a much more proactive approach to risk.
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Who Should Attend:
Quality & compliance managers Risk managers Life science product lifecycle managers & engineers Business leaders
- Skill Level: Novice, Intermediate , Expert
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Topics:
- Tips, tools, and techniques for managing risks
- Why risk-based thinking is a powerful business driver
- Common risk management mistakes to dodge
Speakers
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Kelly StantonDirector of Quality at QualioKelly brings over 20 years of experience in both the pharmaceutical and medical device industry to the world of small start-ups and scalable quality system implementations. Having been an implementer, administrator, and user of many different eQMS tools on the market, she has built several quality systems. Kelly is an advisor to over 20 Medical Device and Pharma companies. She is currently the Director of Quality at Qualio, helping customers and the company adheres to the evolving regulatory landscape. She leads a team of talented industry-experienced quality professionals who work daily with companies in regulated industries.
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Pierre ServanFounder, Factor QualityPierre Servan is Factor Quality’s founder, principal consultant, owner, and leader. He has more than 20 years in the Quality industry. His vision 11 years ago was to help customers fix quality issues, improve their businesses, and help them get certified. He started in the industry in 1997 as a salesperson for an ANAB certification body. Naturally, He developed knowledge and skills that allowed him to start performing certification audits for the same registrar for over five years. After the experiences he had gained, he moved his career into a global semiconductor company where he was a Quality Systems lead and continued learning more about Quality management. Pierre quickly became the North America Quality manager for this organization. In 2011, after seven years as a Quality Manager, he opened his own quality management business. His objective is to help multiple companies manage their quality activities without over-complicating their organizations- “keeping it simple”. He has worked with numerous standards including: ISO 9001, ISO 14001, ISO 45001, ISO 13485, ISO 17025 , AS 9100, and IATF 16949. Pierre’s thirst for knowledge and an equal passion for sharing it has helped Factor Quality grow in the industry. He has had the privilege of speaking as an expert in industry trade shows, conferences, symposiums, and ASQ meetings or workshops. He keeps Factor Quality in sync with the quality industry and ensures that our knowledge is current and valuable for our customers’ benefit. Today Factor Quality focuses on continuing to improve and keeping up with our expertise and experience.
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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4 thoughts on “Mastering Risks and Opportunities in GxP: Tips, Tools & Techniques”
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Great effort continuous education
Looking forward to participate
Honest gap analysis and risk assessment of system, facility ,process, product, equipment etc.
It’s my personal observation that we r forced by management to reduce RPN value..and accept the risk instead to doing actual risk assessment and mitigation plan.
By considering the cost required depends on risk mitigation, management asking to change and modify risk assessment.
Risk assessment and gap asseseny required systematic approach.like brainstorming with team.
Capturing of various option/alternatives/ etc.
Lack of knowledge of person who is performing risk assessment.
As flow chart is primary required to identify various secondary and tertiary component followed by asking question depends on why, excees ,less, without, no interlock, no identification, absent, without etc.
We are not segregating the design, equipment, process, and system fmea,
Anonymous while doing RPN.
Lots more .
Looking forward to the session Yan.
For the other attendees it may be worth looking into the recent ITH Pharma legal case in the UK as an example of what can happen when risks are assessed badly.
Stephen