ICH Q9 and ISO 14971 applicable for quality risk management that can be applied to different aspects of pharmaceutical quality with a management perspective to balance cost vs. risk. Risk Assessment, Control, Communication, Review are significance of effective communication.

1. 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.
Description
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.
Learning Objective:
Understand the principles of Quality Risk Management to:
Identify
Analyze
Evaluate
Control
Reduce
Accept
Communicate and
Review risks throughout product life cycle

2. 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.
Production
Engineering
Quality control
Product development
Marketing and
Regulatory affairs
Instructor Profile:
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.

3. 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.
Topic Background:
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:
Development
Manufacturing
Distribution
Inspection and
Submission/review processes
Throughout the lifecycle of:
Drug substances
Drug (medicinal) products
Biological and biotechnological products