Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971

This 60-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.

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Last Recorded Date: Mar-2019

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Why Should You Attend:

In this 60-minute webinar we will define risk and what constitutes risks primarily per ICH Q9 and reference ISO 14971 where applicable. The presenter will discuss 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 to prepare organizations for regulatory inspections. The session provides quality assurance and formulation development professionals with a management perspective to make the right decisions for their organization in selecting the correct risk tool for the quality risk problems.

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 decision making.

Learning Objectives:

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 Webinar:

Quality Risk Management Overview

  • Understanding Risk
  • Definitions and Concepts ICH Q9 and ISO 14971
  • Risk Assessment
  • Risk Control
  • Risk Communication
  • Risk Review
  • Example of Risk Management Methods and Tools
  • Define Pharmaceutical Excipients
Who Will Benefit:

This training discussion seminar has been designed for quality assurance and formulation development 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 (Formulation and Analytical)
  • Marketing and
  • Regulatory affairs
  • Supply Chain
Instructor Profile:
Tanvir Mahmud Tanvir Mahmud

Founder and Principal, Find Your Solution

Tanvir Mahmud has more than 20 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 master’s 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 and program management.

Tanvir is a consultant and a trainer at QPS and a Founder and Principal at Find Your Solution (FYS) Consulting and Training, a company offering training and consulting in Risk Management and Continuous Quality improvement.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert 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.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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