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Quality Risk Management Overview for Pharma and Biopharma, ICH Q9/ISO 14971
This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.
Why Should You Attend:
In this 90-minute webinar we will define risk and what constitutes risks primarily per ICH Q9 and reference ISO 14971 where applicable. The presenter will discuss principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.
The overall goal of this course is to raise awareness for Quality Risk Management to improve patient safety and also to prepare organizations for regulatory inspections. The session provides quality assurance professionals with a management perspective to make the right decisions for their organization to balance cost vs. risk.
This training provides participants with the knowledge, tools and confidence to understand and participate in a risk management program in a pharma and biopharma industry and an understanding of the significance of effective communication.
Understand the principles of Quality Risk Management to:
- Communicate and
- Review risks throughout product life cycle
Areas Covered in the Seminar:
Quality Risk Management Overview
- Understanding Risk
- Application of ICH Q9
- Definitions and Concepts
- Risk Assessment
- Risk Control
- Risk Communication
- Risk Review
- Example of Risk Management Methods and Tools
Who Will Benefit:
This training discussion seminar has been designed for quality assurance personnel in Pharmaceutical and Biopharmaceutical Industries.
It also addresses staff from other departments too, in so far as they are subject to EU and FDA GMP compliance.
- Quality control
- Product development
- Marketing and
- Regulatory affairs
Tanvir Mahmud, has more than 14 years experience in product development, quality and project management in regulated industries including Biogen Idec, Vertex Pharmaceuticals, Boston Scientific and Consulting Companies. She has a Masters Degree in Physical and Biochemistry and a Master Certification in coaching. Her professional experience relates to research and development, analytical development, formulation development, quality management, chemistry manufacturing and control, drug/device/biologics/combination product stability, training, leadership development and program management.
Tanvir is currently an Adjunct Faculty at Southern New Hampshire University, SNHU, Consultant and a Founder and Principal of Find Your Solution (FYS) Consulting and Training, a company offering training and consulting in Quality Management, employee development and performance improvement. FYS assists companies to achieve results by designing, developing and implementing efficient processes and effective training programs for employee to improve patient outcomes.
Tanvir designs, develops and delivers training in Quality Risk Management, cGMP for ASQ Professional Certification and other customized training for Pharma, Biopharma and Medical Device Industries. Tanvir is a member of the Regulatory Affairs Professional Society, Boston Trainer’s Roundtable, Boston Facilitator’s Roundtable and Project Management Institute.
ICH Q9 provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include:
- Inspection and
- Submission/review processes
Throughout the lifecycle of:
- Drug substances
- Drug (medicinal) products
- Biological and biotechnological products
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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