Practical Implementation of Pharmaceutical Quality Risk Management (QRM)
Instructor:
Steven Laurenz
Product ID: 706012
- Duration: 60 Min
Why Should You Attend:
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.
Learning Objectives:
- Recognize the purpose and value of Quality Risk Management (QRM), as well as how it applies to your job.
- Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions.
- Identify key QRM terminology.
- Recognize the four (4) key components of Quality Risk Management.
- Identify examples of QRM 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
Steven Laurenz
Principal Consultant, BioPhia Consulting Inc
Steven Laurenz has over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. He is skilled in taking new products from early laboratory stage to successful manufacturing launch. He is an expert in integrating Quality by Design and risk management into product development. He has proven experience in establishing a Quality System for a R&D Quality Assurance organization.
Steven has headed product development departments at Abbott Laboratories and AbbVie Inc. and held leadership positions in numerous technical consortium.
Steven Laurenz holds an M.S. in Chemical Engineering from the Michigan State University and a Black Belt certified in Business Excellence and Master Certificate in Applied Statistics.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).
