GMP Problem Solving course

Course overview:

Many pharmaceutical manufacturing sites have gotten into difficulty in the past few years for being unable to deal with problems in a systematic, consistent, compliant and auditable way. With increasing GMP requirements to deal with problems adequately it is inevitable that how an organisation deals with problems, incidents and deviations will be inspected more closely at regulatory inspections. In order to avoid difficulties both now and in the future make sure you are up to date with current tools and techniques needed to deal with problems in an effective, efficient and compliant way.
Our highly interactive Pharma Problem Solving course introduces delegates to a wide range of problem solving tools that can be used to help solve problems that occur in a pharmaceutical environment. During the course a large number of methods that can be used to deal with problems are introduced, explained and examples provided of when they may be used.  The course focuses on ensuring that the correct cause of a problem is identified, that the right measures are employed to deal with the problem and that monitoring occurs to ensure that the problem has been solved for good.  In addition the Pharma Problem Solving course looks at common reasons for problems and highlights how many systems have inadequacies within them that actually cause problems themselves.

Who will the course benefit?

Our Pharma Problem Solving course is aimed principally at anyone needing to be involved in problem solving within a pharmaceutical environment, including Quality Assurance, Quality Control, Engineering, Production and Process Improvement personnel.

Course location:

UK courses (Reading, Berkshire)
The Holiday Inn – Reading South, 500 Basingstoke Road, Reading, Berkshire, RG2 0SL, UK. The hotel is very close to Junction 11 of the M4 – 25 miles west of London’s Heathrow Airport.
Telephone: + 44 (0)871 942 9067
e-mail: [email protected]
Web: http://www.hireadingsouthhotel.co.uk
A special rate of £121 (including VAT) has been agreed with the hotel (subject to availability). This is for Bed and Breakfast and includes internet access. Quote “Inspired Pharma” when making your booking.

Course cost:

£1190  per delegate plus VAT. Course will be charged in GB pounds.

VAT will not be charged for courses held outside the UK. VAT will be charged for the courses held 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 coming from outside the EU.

The cost of accommodation is not included in the course cost. If required you should book accommodation yourself directly with the hotel.

The cost includes:

• Refreshments and lunch during the course times.
• Course folder containing copies of slides and supplementary notes and handouts.
• Course attendance certificate.
• Full tutor support and access during course times.

Payment can be made by cheque, electronic transfer, credit or debit card. Payment must be made before the course start date. Either payment or a Purchase Order number will be required to secure a place on the course.

To book a place on our GMP Problem Solving course please use the online booking system by selecting the ‘Book Now’ button on the event of your choice (at the top of the screen/page)

Previous feedback:

“Great tutors- engaging and fun to learn”
Upstream Scientist, Allergan
“Discussions were very good”
QA Manager, PHE
“Excellent – well delivered and great content”
Analytical Scientist, Allergan
Very useful, relevant and addressed key issues”
QA Specialist, Actavis Biologics
“More fun than expected”
Buyer, GR Lanes
“Thank you very much – I thoroughly enjoyed the course”
QA Specialist, Actavis Biologics
“Kept everyone captivated”
Team Leader, GR Lanes
“Great content and lively presentations”
Production Team Leader, Actavis Biologics
“Excellent as always”
QA Manager, PHE
“Excellent materials – the time flew by”
Senior Production Operator, Actavis Biologics

Dates:

See top of this page for current public dates. Also available for in-house delivery, and may be customised if required.

Times: 

Day 1 09.00 – 16.30 Day 2 09.00 – 16.00

Tutors:

Peter Lavis

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

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:

• Types of problems and deviations
• GMP requirements for dealing with and documenting problems
• The new GMP Chapter 1 and Chapter 8 requirements for Problem Solving
• Tools used to grasp the situation
• Data gathering tools:
  • Charts and Graphs
  • Fishbone Diagrams
  • Brainstorming
  • Is/Is not, 5 “W”‘s and a “H”
• Root-Cause Analysis tools:
  • Cause and Effect
  • Pareto Analysis
  • 5-Whys
• The differences between Correction, Corrective Action and Preventive Action
• Ensuring that the true cause is found
• Monitoring actions to confirm the correct steps have been taken
• Common reasons for problems
• Human error – or not?
• Problems with communication, documentation and training
• Being more proactive and less reactive
• Continual improvement mechanisms
• Managing deviations and outstanding actions
• The role of Senior Management with Problem Solving
• Risk management tools, such as HACCP and FMEA and how and when these can be used
• Documenting Deviations and Problems in a compliant manner