Quality Risk Management Overview


OVERVIEW
After attending this course the audience will
  • 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 Quality Risk Management tools and their application.
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.
AREAS COVERED
  • 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.
LEARNING OBJECTIVES
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.
WHO WILL BENEFIT
This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products especially small molecule oral dosage forms. 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. 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

For more detail please click on this below link:
http://bit.ly/2NzPg9e


Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882



Comments

Post a Comment

Popular posts from this blog

Small Business Management Made Simple:Tools, Tips & Techniques for Successful Business Management

Image
OVERVIEW Many business owners and managers have excellent product ideasthat could be very profitable.   However, their enterprises are not as successful as they could or should be.  This is typically due to their lack of a basic understanding and foundation of the tools and techniques needed to successfully manage a business.  This webinar is a summary of simple tools and techniques needed to be successful at managing a business. It also offers helpful hints and bits of wisdom included in thespeaker’s published handbook – Small Business Management Made Simple! This handbook is based on his 30 years of business management, ownership and business coaching experience. How To Start Own Business WHY SHOULD YOU ATTEND The handbook and webinar were developed with the business owner/manager in mind.  It covers all the significant items needed to succeed in business, based primarily on personal experiences and knowledge acquired in the actual management of various business ente
Read more

SharePoint Site Owner – Setting Up and Managing Your SharePoint Site

Image
OVERVIEW Microsoft Office SharePoint  has become the standard way for companies and organizations to share relevant info and files with other people in the company and with people outside of the company as well. In this webinar, you will learn how to set up a  SharePoint  site and manage it well. how to set up a sharepoint site WHY SHOULD YOU ATTEND So, your company has switched over to Microsoft Office SharePoint. Maybe some people in your company have set up their own sites. And then, your boss tells you that you are going to be in charge of your department’s SharePoint site. What do you do? Where do you even start? This webinar will show you how to set up a SharePoint site and manage it as well. If you are in charge of Microsoft Office SharePoint or SharePoint site permissions, or if you are going to be, you need this SharePoint administration training. AREAS COVERED Microsoft SharePoint overview Screen tour Adding logos and colors to your site Adding u
Read more

Coronavirus Risks and Opportunities - Ensuring Safe Business Operations in Compliance with the Updated Laws

Image
  OVERVIEW This webinar will provide an overview of measures that businesses can take to reduce their vulnerability to further disruption by COVID-19 and similar illnesses while they protect workers and other stakeholders such as customers, and also contribute to public health by "flattening the curve." The good news is that there is a wide array of proven off-the-shelf countermeasures such as social distancing, workplace controls, and face masks that impede the spread of contagious diseases. OSHA has already released authoritative guidance that is likely to be embodied in a formal standard later this year, but proactive organizations can have most of the requirements in place before they become mandatory. Many jobs can be performed remotely which eliminates the risk of contagion completely, and also reduces costs of a physical presence such as office or classroom space, and commuting and lodging costs. Organizations must also reassess supply chain vulnerabilities to forc
Read more