Pharmaceutical Quality Risk Management (QRM) Overview

Duration: 60 Minutes
Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. However integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization. There is much confusion on how to define risk and individuals often think of quality risk management as just a tool like FMEA analysis verses an overall QRM approach. This training will explain the important concepts associated with a QRM approach.
Pharmaceutical Risk Management Plan
Instructor: Steven Laurenz
Product ID: 506610
Objectives of the Presentation
  • Understand the key points of US requirements, citations and expectations that may influence the implementation of a QRM process
  • Learn how to implement a risk decision tree and the appropriate use of risk assessment tools
  • Identify specific strategies for defining the criteria for risk ratings and risk mitigation requirements
  • Know how to apply risk management methodologies throughout the product lifecycle
  • Understand how risk assessments align with the overall implementation of a robust QRM system that is applicable for the product lifecycle
  • Understand best practices and lessons learned from implementing QRM and how to facilitate effective risk assessmentsv
  • Outline a Quality Risk Management Plan enabled by an understanding and the application of a lifecycle-based QRM process, inclusive of risk ranking
Why Should you Attend
Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM, explain the level of risk based on severity, occurrence, and detect ability and how the QRM process is used to make decisions. In addition they will be able to identify key QRM terminology and recognize the four (4) key components of Quality Risk Management. Finally they will have a strong understanding of the key concepts associated with the risk management, risk tools and their application.

Who will Benefit
This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products. This includes individuals that have responsibilities for formulation development, scale-up, filing, and commercial manufacture of dosage forms as well as maintaining the high quality of those products. In addition other related industries will benefit. Following personnel will benefit from the course:
  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Development professionals
  • Senior development managers
  • Risk Management
  • Quality assurance/control
  • Project engineers and managers, commissioning, validation, engineering and service providers
  • Manufacturing operations and facilities professionals
$375
Recorded Session for one participant
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Live Session - How it works
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization.

Experience: Headed product development departments at Abbott Laboratories and AbbVie Inc. Leadership positions in numerous technical consortium.
Other: Black Belt certified in Business Excellence and Master Certificate in Applied Statistics.
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