Skip to main content

Pharmaceutical Quality Risk Management (QRM) Overview

Compliance Key INC - Enterprise Risk Management training
                                                STEVEN LAURENZ
Steven Laurenz- Chemical Engineering M.S. - Michigan State University Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization.

  Webinar Id:  LSHCST001
 10:00 AM PT | 1:00 PM  ET 
 01/24/2018
 Duration: 60 mins 
Overview
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. 
Why should you attend this webinar?
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 detectability 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. 
Areas Covered in the Session:
  • 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 can 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.

Labels:
Location: United States

Comments

Post a Comment

Popular posts from this blog

HIPAA changes 2018 and How to comply?

Compliance Key INC  -  HIPAA W ebinar                                                   Brian L Tuttle Brian Tuttle is Keynote Speaker at Compliance key Inc . He is Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor (CBRA) with over 17 years experience in Health IT and Compliance Consulting.     Webinar Id:   HIPHBLT001 10:00 AM PT | 01:00 PM ET  01/23/2018 Duration: 90 mins  Overview This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump administration, and any other applicable updates for 2018 and beyon...
Post a Comment
Read more

Strategies for Becoming a Business Partner to Your Healthcare Leaders.Compliance Key INC -

Compliance Key INC  -  Healthcare Training Online                                                    Jay Anstine Mr. Anstine's professional background includes working on the provider and the payer side of the market, for large for-profit and non-profit health systems, and small physician-owned entities. In tackling the countless regulatory and operational issues for these diverse organization types, he has developed a deep understanding of the business of healthcare and the regulations that govern the industry.  Webinar Id:  LSHCSJA022  10:00 AM PT | 01:00 PM ET  12/13/2017  Duration 60 mins  Overview All too often compliance is seen as an obstacle or otherwise viewed negatively by healthcare leaders. This presentation will discuss strategies and insights to help the compliance of...
Post a Comment
Read more

Form I-9 Compliance For Small Business

Compliance Key INC  -  Compliance Online Training                                  Matthew W. Burr Matthew Burr has over ten years of experience working in the human resources field, starting his career as an Industrial Relations Intern at Kennedy Valve Manufacturing to most recently founding and managing a human resource consulting company; Burr Consulting, LLC. He specializes in labor and employment law, conflict resolution, performance management, employee relations and work with labor unions.   Webinar Id:  CICMF001  12:30 PM PT | 03:30 PM ET  11/28/2017  Duration 60 mins  Overview This training will focus on the importance of I-9 compliance for small businesses. The training will introduce the I-9 forms, importance of filling out the forms correctly, retention process and proactive I-9 audits. We will also ...
Post a Comment
Read more