Course overview

This Pharma Quality Management Systems course explains how to establish, manage, monitor and continually improve a forward thinking modern Pharmaceutical Quality Management System that adds real-value to your organisation. The course covers current principles on Pharmaceutical Quality Management Systems (PQMS) and includes the FDA’s “Guidance for Quality Systems” and ICH Q10 “Guidance on Pharmaceutical Quality Systems”. These guidelines explain the evolving nature of QMS thinking, with a focus on organisational effectiveness and efficiency rather than just product quality and GMP. We also include the ramifications to a pharmaceutical company of the recently updated EU GMP Chapter 1 on Pharmaceutical Quality Management Systems and Chapter 2 on Personnel. These both have a major impact on the role of Top Management within an organisation.
Delegates will leave the Pharma Quality Management Systems course with a clear understanding of how to successfully integrate GMP, ICH Q8, 9 & 10 and ISO 9000 principles into a compliant, effective, efficient and continually improving QMS for the whole business, as well as the role of Quality Personnel in re-shaping quality thinking to move with the times to meet today’s business challenges.

Who will the course benefit?

This Pharma Quality Management Systems course is aimed at busy professionals working in the Pharma industry who need to understand how a forward thinking modern Pharmaceutical Quality Management System can add real-value to their organisation. It is especially valuable for Quality Professionals, especially those working in Quality Assurance and Quality Improvement roles, as the course provides an eye-opening view of modern quality management thinking.

Cost: £795

VAT will be charged for delegates doing the course who are based in the UK. However delegates from outside the UK but within the European Union (EU) will not be charged VAT if they supply their own company’s national VAT number when booking. VAT will not be charged for any delegates from outside the EU.

The cost includes:

• Access to the on-line learning platform for 12 months.
• Course notes containing copies of slides, notes and handouts.
• Tutor support provided.
• A course certificate on completion of the course.

Unit 01: The Evolution of Quality Management Systems

• Introduction to the course
• The concept of Quality and Quality Definitions
• The concept of Quality Management System thinking
• The evolution of Quality Management System thinking
• Good Manufacturing Practice – EU and USA GMP
• Pharmaceutical principles of QA, GMP and QC
• Traditional GMP and modern QMS thinking

Unit 02: How to Design a Quality Management System

• The design criteria for an effective QMS
• Comparison of ISO 9001 and GMP
• Pharmaceutical QMS evolution
• The FDA’s Quality System Model & ICH Q8, 9 & 10
• Documentation systems, documents and record keeping
• Organisational structures, reporting relationships and review
• The design, selection and qualification of premises, equipment, utilities and services
• The concepts associated with risk management
• Additional guidance for those starting a new QMS

Unit 03: How to Implement a Quality Management System

• Assigning roles and responsibilities
• The roles of the Heads of Production & QC and the Qualified Person
• The role of QA and their interaction with other departments
• The roles and responsibilities of Top Management
• Training and evaluation
• The skills and competencies needed to provide effective GMP training

Unit 04: Half-way on-line assessment

Unit 05: How to Maintain a Quality Management System

• Review of the system so far
• Purchasing and supplier qualification
• Supply chain, materials control, brokers, distributors and repackagers
• Outsourcing and technical agreements
• Production planning, scheduling and inventory control
• Deviations and change control
• Calibration and preventive maintenance

The benefits of this programme?

• Designed for busy Pharma professionals who want to fit short 15 to 30-minute chapters of learning into a hectic work schedule and cannot afford three, four or five days out of the office
• Course notes (delegate pack) available to print and keep.
• Do the course when you like – no need to attend on specific days.
• Convenience – access anytime at home or at work.  All you need is internet access and a computer, iPad, iPhone or tablet.
• Assessments throughout the course to check understanding.
• Tutors contactable via phone or email (UK office hours).
• The course fee is the price you pay – no hidden or extra costs of travel, accommodation and meals.
• Why not give us a try? Others have and were really impressed. To try a free taster of these courses to see if they are of interest visit this page.

Previous Delegate Feedback

Dominic Parry

Dominic Parry has worked in the pharmaceutical industry since 1992 and is a leading pharmaceutical quality management specialist.  He initially worked for Evans Medical Limited as a Production Development Scientist.  He then moved to Hoechst Marion Roussel where he worked as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.

Over the past 20 years he has worked as a leading pharmaceutical trainer and Quality Management System specialist.  He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems so that they add real-value to organisations.  He has a real passion for training in the pharmaceutical industry and has presented GMP and Quality Management related training courses all over the world.  He is an IRCA registered GMP Lead Auditor and regularly performs audits of pharmaceutical companies and their suppliers.