You are on page 1of 3

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

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.

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