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.
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.
It also addresses staff from other departments too, in so far as they are subject to EU and FDA GMP compliance.
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 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
- Regulatory affairs
- Supply Chain
Speaker
Tanvir MahmudCourse Provider
Tanvir Mahmud,
