Course overview:

This 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 of 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 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 course is aimed at anyone working in pharmaceutical Quality Assurance who need to know how to establish, maintain, monitor and improve a modern Quality Management System that focuses on product quality, compliance to GMP and the needs of the business.  This course is also of value to any Quality Professional, especially those working in Quality Assurance and Quality Improvement roles, as the course provides an eye-opening view of modern quality management thinking.

NOTE – an online version of this course is also available as well as a version for trainee Qualified Persons (QPs).  The online version covers some additional content as required in the UK QP Study Guide.

Course location:

Available in-company at a venue of your choice

Course cost:

If you would like to discuss your requirements and get a quotation please send us an email

Previous feedback:

“Tutors were very knowledgeable and enthusiastic”
QA Officer, TEVA RUNCORN

“Excellent – I learnt an awful lot”
QA Officer, TEVA RUNCORN

“Tutors are brilliant”
QC Analysis, NORGINE

“Intense – but delivered so well I enjoyed it”
Shift Leader, NORGINE

“Thank you very much for an enjoyable 2-days”
QA Officer, CATALENT

“Lots to take in – intense but enjoyable”
QA Officer, CATALENT

“A completely new way to look at the QMS”
Quality Manager, AMDIPHARM

“Both trainers were very enthusiastic”
Quality Systems Executive, AMCo

“A really helpful and interesting course”
Quality Officer, AMDIPHARM

Dates:

Only available in-company

Times: 

A 2-day course with start times as follows:

Day 1:  09.30 – 17.00        Day 2:  09.00 – 16.30

Tutors:

Dominic Parry

Dominic is a highly respected GMP trainer with extensive GMP and Quality Management System experience, his reputation for delivering high-quality training courses is recognised worldwide. He has been involved in presenting inspiring GMP training courses for over 10 years with outstanding feedback received.  He has over 20 years of pharmaceutical experience in Production, Quality and more recently Training and Consultancy roles.  He is a Director of Inspired Pharma Training Ltd.

Course contents (can be customised):

Day 1     Quality Management Systems – foundations

• Quality principles & definitions
• The evolving concept of Quality, Quality Assurance, Quality Control and Quality Management System thinking
• Good Manufacturing Practice and Quality Management
• Principles and structure of EU GMP.
• Quality Management in EU GMP – the “traditional stance”
• Evolving Quality Initiatives
• The Drivers and Shapers of Change
• Quality Management Systems and ISO 9001
• Ramifications on GMP
• GMP Quality Evolution – ICH Q8, 9, 10 and FDA Guidance
• Updates to EU GMP Chapters 1 & 2

Day 2     Quality Management Systems – evaluation and improvement

• A revised role for the Quality System
• The role of Senior Management
• A revised role for Quality Assurance
• Batch review and Product Quality Review
• GMP metrics – Deviations, Corrective Actions and Complaints
• Process monitoring
• The internal audit mechanism
• Customer Focus and Continual Improvement
• Correction, Corrective Action, Preventive Action and Root Cause Analysis
• The importance of clear Roles and Responsibilities
• The importance of good communication
• Good documentation
• The importance of training and evaluation