Designing and Implementing an Effective Quality Management System (QMS)

A QMS is a coordinated set of values and processes implemented by an organization to ensure that it meets the standards demanded by its customers and any key stakeholders. The ISO 9001:2015 standard is the relevant international standard that sets out the broad requirements of a quality management system.

A fully operational QMS will help an organization to meet key operational targets and demonstrate to any interested parties that it has achieved those goals. It will show that your organization consistently meets customer requirements, consistently manages internal requirements and consistently manages external requirements, e.g. the effective allocation of resources.

This training will discuss the benefits of implementing a QMS. It will describe how a QMS supports an organization and what a QMS requires. This training will provide guidance for operating in a controlled environment and instruct attendees on the steps to take in order to implement an effective and robust Quality Management System.

Implementing a quality management system will result in a number of long-term commercial gains such as;

• Achieving organizational goals with ease
• Reducing costly errors and wastage
• Boosting customer satisfaction
• Marketing your business more effectively
• Managing growth more effectively
• Improving documentation availability
• Protecting sensitive data
• Correcting issues to continually improve products and services
• Creating a culture of quality

• What is a Quality Management System (QMS)?
• Why is a QMS important?
• The benefits of implementing a QMS?
• How does a QMS support an organization to manage cultural issues?
• Requirements of a QMS (ISO 9001:2015)
• The 4 components of a QMS
• The 7 principles of Quality Management
• Steps to implementing a QMS.

This webinar is for individuals responsible for Quality management and support such as:

• Quality managers
• Process owners
• Project managers
• Those involved in regulatory compliance
• Those responsible for implementing and maintaining a quality management system (QMS).
• Supervisors and Managers in Pharmaceutical or Biological Laboratories
• Quality Control and Quality Assurance Analysts

Instructor Profile:

Joy McElroy

Principle Consultant, Maynard Consulting Company

Joy McElroy has 10 years of experience as a consultant and over 30 years of total experience in the pharmaceutical and biotech industries. Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, and equipment qualification. She worked in Quality Control and Quality Assurance for several years before moving into validation and qualification. She has written and executed equipment qualification and validation protocols for numerous companies.

Ms. McElroy specializes in manufacturing equipment qualification, sterilization, cleaning validation, analytical instrument qualification, computer system validation and GMP compliance auditing. In 2019, Ms. McElroy started her own company, McElroy Training and Consultancy. She currently works with Actalent Services, LLC.