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

Instructor: Tanvir Mahmud
Product ID: 702422
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Nov-2012

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

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.

Course "Quality Risk Management Overview for Pharma and Biopharma, ICH Q9/ISO 14971" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

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
Follow us :
Seminars by Ex-FDA Officials
Latin America: Regulatory Compliance Requirements for Life Science Products

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. 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.

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 call +1-888-717-2436 (Toll Free).

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