Pharma Quality Management Systems online course

Learn how to establish, monitor and improve a modern Pharmaceutical Quality Management System taking into account Good Manufacturing Practice (GMP) requirements and recent changes in GMP's requirements for Quality Systems.

The Pharma Quality Management Systems course is available on-line using a desktop pc, laptop, tablet or even a smart phone. Course details are shown below:

QP Module Duration and price Click below to book a place
Pharma Quality Management Systems online course Around 25 hours online learning – £795 Pharma Quality Management Systems online course

If you plan to pay by credit card then you should first look at this helpful informationOther payment options are available – see below for details.

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 6 months.
  • Course notes containing copies of slides, notes and handouts.
  • Tutor support provided.
  • A course certificate on completion of the course.

Payment can be made by cheque, electronic transfer, credit or debit card. Login details will be sent shortly after payment has been made.

Study Anytime anywhere:

 This course is of about 25 hours duration – the equivalent to a 3-day classroom based training course. The chapters of the course are each done in your own time. Work through the course materials when you like! The course is presented in short bite-size chunks with assessments throughout to check your understanding. Tutor support is available via telephone and email.

To access a free Taster of the programme including 3 Chapters please complete the details below to get a link to the course. These details will be used to keep you in touch with us.

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To access the Taster chapters from the course  click here>>>

 

View the short video below to understand more about this unique approach (this course uses the same style of learning and share many of the same chapters as our QP course):

Feedback from delegates:

“This course is inspiring”Pharmaceutical Consultant
“I liked the course very much and wish to do other modules”QA Manager, Astellas
“Well structured and informative”Qualified Person, Monrol
“The course is informative, well-structured and easily digested”Pharmaceutical Consultant
“I will definitely recommend it for other colleagues”QA Manager, GlaxoSmithKline

Tutors:

Peter Lavis
peter

Arguably the finest Quality Management Systems tutor in the business, Peter’s enthusiasm for quality system thinking and his outstanding training abilities have gained him international praise and appeal. Peter is a leading quality management systems auditor and encourages auditors to think outside the “GMP box”.

Dominic Parry
dom

Dominic Parry has worked in the pharmaceutical industry since 1992, and is a leading pharmaceutical quality management specialist. He worked for 4 years at Evans Medical Limited (now Novartis Vaccines) as a Production Development Scientist. He then moved to Hoechst Marion Roussel (now Patheon, UK), where he worked for 4 years as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.Over the past 15 years he has worked as a leading pharmaceutical GMP trainer and Quality Management System specialist. He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems.He is generally recognised as one of the leading GMP trainers in the UK and brings an enormous amount of interest, enthusiasm and fun into the training he presents. He is Managing Director of Inspired Pharma Training Ltd.

Course contents:

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

Unit 06: How to Evaluate a Quality Management System

  • Annual Product Quality Reviews
  • Economic and statistical indicators
  • Staff Appraisals and Performance Management
  • Management ReviewAuditing and self-inspection
  • The collection and analysis of data

Unit 07: How to Improve a Quality Management System

  • Customer complaints and satisfaction monitoring
  • Correction, Corrective Action and Preventive Action
  • Quality metrics – GMP and beyond
  • The Process Approach
  • Process based auditing
  • Internal customer focus
  • Interpersonal skills and required behaviours

Unit 08: Miscellaneous

  • Course summary
  • References and useful web-sites

Unit 09: Final on-line assessment