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 online course is available online using a desktop pc, laptop, tablet or even a smartphone.
It has been 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.
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Pharma Quality Management Systems online course
Available: Anytime Anywhere using a desktop pc, laptop, tablet and most smartphones
Duration: Around 25 hours online learning
Cost: £795 plus VAT per learner (see below for details)
If you plan to pay by credit card then you should first look at this helpful information. Payment can be made by cheque, electronic transfer, credit or debit card. Login details will be sent shortly after payment has been made.
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.
To try a free Taster course including 3 Chapters of the programme subscribe by clicking on the link in blue in this sentence.
Key Course Information
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.
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.
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. Once you are assigned to the Course you have 12 months to complete the programme.
To try a free Taster course including 3 Chapters of the programme subscribeby clicking on the link in blue in this sentence.
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
Why choose this course?
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 course including 3 Chapters of the programme subscribe by clicking on the link in blue in this sentence.
Previous Delegate Feedback
The experts who have designed and built this course:
Peter is arguably the finest Quality Management Systems tutor in the business, his enthusiasm for quality system thinking and his outstanding training abilities have gained him international praise and appeal. He is an IRCA registered Quality Management Systems Lead Auditor. Peter is an enthusiastic trainer with over 30 years of quality and industrial experience, including spending the past 15 years working closely with pharmaceutical organisations small and large.
Dominic Parry has worked in the pharmaceutical industry since 1992, and is a leading pharmaceutical quality management specialist. 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.
Ron has been involved in the learning and development industry for over 20 years. He is a Fellow of the Learning and Performance Institute and in 2004 received the LPI ‘Colin Corder’ award for outstanding services to the training industry. He is the architect behind our website and our learning platform and also develops the web-based learning courses that we now offer to support many of our learning programmes. In addition, he also provides general business support on strategy and sales and marketing.
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About Inspired Pharma
We help people in Pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.
We offer a wide range of highly praised and respected classroom and online training courses and also provide our global pharma clients with consultancy support. Our classroom courses are available on a public schedule and also can be customised for inhouse delivery at a client site.
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