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GMP Problem Solving and Root Cause Analysis course

Make sure you are up to date with current tools and techniques needed to deal with Pharma problems in an effective, efficient and compliant way. This course is now delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together.
Key InformationWhy Inspired?

Deal with GMP problems in an effective, efficient and compliant way

This highly interactive one-day GMP Problem Solving course will allow you to learn and practise a wide range of problem-solving tools to help you address your deviations, incidents and issues. From documenting the problem, through effective Root Cause Analysis, to confirmation of the effectiveness of corrective actions, delegates will leave the course with the knowledge and skills necessary not only to identify, document and solve problems, but to avoid these problems occurring in the first place. 

Inadequately dealing with problems, not identifying root-cause and not implementing effective corrective actions are becoming one of THE major findings at regulatory inspections. This course will give confidence that problems are addressed in a systematic, consistent, compliant and auditable manner.

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Make a Booking

Our one-day GMP Problem Solving training course is available on the following dates:

Tuesday 24th November 2020

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

Thursday 10th June 2021

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

Tuesday 23rd November 2021

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

Coronavirus Update

Due to the uncertainties involved in travel at the moment we will be delivering all of our public courses using our proven 'live online interactive' technology. Delegate feedback from the courses we delivered in June and July has been just as positive as our classroom courses and in addition, many people have enjoyed not having to travel in these difficult times.

All Dates:

The cost is £695 plus VAT. Course will be charged in GB pounds. For full details of what is included in the cost see below.

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.

If you plan to pay by credit card then you should first look at this helpful information.

Alternatively, if you want to discuss any aspect of this course or want to reserve a place, please send an email with your enquiry or call +44 1635 866699.

Based outside the UK?

If so, be sure to pick the 'Tax Exempt' options in the payment method list when you are  making a booking. If you are based in the EU then you must also enter your VAT number to qualify to be exempt from VAT.

Group Bookings - discounts of up to 50% 

Book 2 or more individuals from the same company for the same course date to enjoy substantial discounts. The first booking is charged at the full published rate with the second booking charged at full published rate minus 20%. A third or fourth booking is charged at full published rate minus 50%. These discounts are applied automatically when you make a booking.

Key Course Information

Who will the course benefit?

Our GMP 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 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.

Course content

  • Types of problems and deviations
  • GMP requirements for dealing with and documenting problems
  • 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
  • Risk management tools, such as HACCP and FMEA and how and when these can be used
  • Documenting Deviations and Problems in a compliant manner

 

Course cost:

£695  per delegate plus VAT. Course will be charged in GB pounds.

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 includes:

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

    Times: 

    09.00 – 17.00 consisting of four 90 minute live interactive online sessions and 3 breaks of at least 30 minutes

Live Online Interactive Training

Stay Safe - Attend from home or whilst at work

With 2 expert facilitators and a maximum of 10 delegates our course will utilise state-of-the art interactive online classroom software that will enable you to:

  • chat online with the facilitators and other delegates
  • raise your 'virtual' hand to ask a question
  • participate anonymously in a poll or survey and see an instant display of the class results
  • undertake exercises on your own or in a group

And best of all, no travel is needed nor a stay in a hotel reducing any risks of COVID-19 and saving you a lot of time, hassle and money. 

As always we will ensure this event is inspirational, enjoyable and educational. See the feedback below:

What is involved?

We will send you a link to the live online interactive course with your joining instructions once you have booked your place. 

You should log into the training session 10-15 minutes before the start time, to ensure that you have set up the courseware  correctly. The course will start precisely on time and it may not be possible to go back over material missed by late arrivals.

Your active participation is expected: everyone will be heard and seen throughout, just as they would be if we were in a room together. To be heard, hear and be seen you will need a microphone, speakers and camera — if you have a modern laptop that’s all you will need. Remember, you’ll need a quiet place to call from and a decent internet connection is a must.

I found the interaction very good by using the chat option as it keeps everyone interested and there was a variety of questions and answers.

Quality / EHS Specialist, DCC VITAL

Great course, although it was virtual I felt we got the same value for money as if it was F2F, a 10 out of 10!!! I will recommend to colleagues

Quality Executive, ABPI

The GMP course was ran very well. Both presenters were very knowledgeable in the area, both for the EU and other countries. I would highly recommend this course to those who are new to the area of GMP, as well as those who just need a bit of a refresher.

 

Training Officer, THORNTON & ROSS

Why choose Inspired Pharma?

Expert Tutor

Matt Morris

Matt Morris

Matt is a dynamic, energetic and authentic trainer who demonstrates his passion and communicates this to all who encounter him. He began his Pharma career at Napp Laboratories before having short spells in related industries. He then spent 15 years with GlaxoSmithKline gaining extensive knowledge of GMP from roles in Packaging, Logistics and QC.

More recently, Matt worked as GMP Learning and Development Manager for Lonza Biologics and draws on all his varied experience to create a lively, relevant training environment.

Dominic Parry

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.

Delegate Feedback

Great tutors – engaging and fun to learn

Upstream Scientist, ALLERGAN

Very useful, relevant and addressed key issues

QA Specialist, ACTAVIS BIOLOGICS

More fun than expected

Buyer, GR LANES

Excellent as always

QA Manager, PHE

Kept everyone captivated

Team Leader, GR LANES

Excellent materials – the time flew by

Senior Production Operator, ACTAVIS BIOLOGICS

A good introduction to the subject. Excellent – well delivered and great content

Analytical Scientist, ALLERGAN

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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.

Quick Links

Find your way quickly to any  part of our website by selecting any of the links in this section:

Forthcoming Public Courses

All of our public courses are being delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together.

Click on course name for full details:

2020

September 

29 Advanced GMP

October

06 Responsible Person

06 Data Integrity 

09 Good Distribution Practice

12 Pharma GMP Lead Auditor

20 Good Manufacturing Practice

21 Sterile Products

November

10 Internal Auditor

16 Pharma GMP Lead Auditor

24 Problem Solving

30 Pharma GMP Lead Auditor

December

08 Responsible Person

15-17 Multi-day GMP

Online courses available anytime anywhere 

Data Integrity

Good Distribution Practice (GDP)

Good Manufacturing Practice (GMP)

Pharma Quality Management Systems module

QP Medicinal Chemistry & Therapeutics module 

QP Quality Management Systems module

Each course typically consists of 10-20 minute chapters of content followed by a quiz based assessment. The QP courses feature tutor assessment too. The learning is accessed over the internet using desktop computers, laptops, tablets and even smartphones.

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