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Defining Risk and Risk Levels: Implementing ICH Q9 - Quality Risk Management
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
February 15, 2017
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11:00 am EST, 10:00 am CST,
9:00 am MST, 8:00 am PST
The seminar will run for one hour.
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(Note: Washington DC and New York are in the EST)
This web seminar will focus on issues outlined in the ICH Q9 Guidance to industry on Quality Risk Management. We will begin by defining what risk is and where risk can be found. We will proceed by defining where risk can be encountered. Once we accomplish this we will address the issue of risk quantification and how to address risk in the drug manufacturing industry.
An outline of a risk assessment form that could be used to define risk level and quantify a Risk Priority Number (RPN) will be presented. The discussion will introduce risk mitigation and prioritization in the context of Corrective and Preventive Action (CAPA) and review some real life examples of risk mitigation actions.
Specific topics to be covered include:
- What ICH Q9 proposes for the concept of Risk-based Compliance
- How to define Risk Factor Levels
- How to assign a Risk Priority Number (RPN)
- "Action Commensurate with the Level of Risk" concept - Why is it important?
- Using Risk-based Compliance and how to use the RPN to prioritize mitigation efforts and resources utilization
- Outline a recommended Risk Form
This seminar will be conducted using GotoMeeting.com and is presented by Gamal Amer, Ph.D., an industry expert on this and other compliance related topics.
In this unique web seminar format, lasting just one hour, you will be able to follow along with a PowerPoint presentation, ask questions, and interact with Dr. Amer. Dr. Amer's qualifications can be found below.
The log-in information and a handout presentation file (to use as a backup) will be sent to you via email the day before the seminar.
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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the presentation handout materials the day before the seminar.
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Gamal Amer, Ph.D.
Gamal Amer, Ph. D. is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over two decades experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations.
Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AIChE.
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