For course details click on the subject areas shown in menu below. To contact us: +44 1635 866699 [email protected]

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.

Key features of our 1-day GMP Problem Solving course: 

Lively and highly interactive course

Our course format is designed to ensure that  this is a lively and highly interactive course with practical workshops and exercises throughout the programme. See the incredible feedback from delegates about our ‘live online interactive ‘ courses  in this article.

Maximum class sizes

For maximum interactivity and effectiveness, our class size is limited to  either 10 delegates  (live online interactive)  or 12 delegates (classroom) with at least two tutors. The quality and effectiveness of our courses is unrivalled in the industry.

Make a Booking

2021

Venue for all dates: Your home or workplace using our proven ‘live online interactive’ courseware. From the list below select the date you want to make a booking (dates in blue are ‘Waiting List’ only):

Tuesday 23rd November 2021

Click here to book

Booking details

Select the tabs below to find out all the details you need to know to make a booking:

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.

What's included in cost

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.

Payment

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 RP training 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.

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

Key Course Information

Is this course right for you?

Click on the tabs below to find out if you will benefit from attending this course:

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 Times:

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

Course Details

Click on the tabs below for more details on the content of the 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.

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

Live Online Interactive Training

This course is currently only available using our proven ‘live online interactive’ format. Select the tabs below to find out more:

Stay Safe - Attend from home or whilst at work

With 2 and sometimes 3 expert facilitators and a maximum of 8 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?

For this certified course IRCA lay down strict requirements in terms of the hours of learning (40+), continuous assessment and the supervision of the exam. This means that you will need to undertake just over 3 hours of online learning prior to the 5 day event and that the event itself will be very intensive and includes evening work – see Timetable details above. It is very important that during the 5-day event you focus totally on the course and that distractions are minimal.

We will send you detailed joining instructions once you have booked your place and in sufficient time for you to undertake the pre-course work.. 

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.

Why choose Inspired Pharma?

Expert Tutors

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 has worked in the pharmaceutical industry since 1992 and is a leading pharmaceutical quality management specialist.  He initially worked for Evans Medical Limited as a Production Development Scientist.  He then moved to Hoechst Marion Roussel where he worked as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.

Over the past 20 years he has worked as a leading pharmaceutical trainer and Quality Management System specialist.  He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems so that they add real-value to organisations.  He has a real passion for training in the pharmaceutical industry and has presented GMP and Quality Management related training courses all over the world.  He is an IRCA registered GMP Lead Auditor and regularly performs audits of pharmaceutical companies and their suppliers.

sterile products courseAndy Martin started working in the Pharmaceutical industry in 1985 for Smith & Nephew.  Following this he had a number of roles culminating when he took over as QA Microbiology Manager and then latterly as Microbiology Manager for Catalent Pharma Solutions.  In 2012 he became a consultant specialising in Pharmaceutical Microbiology and Quality Systems.

Delegate Feedback

Great tutors – engaging and fun to learn

Upstream Scientist, ALLERGAN

Kept everyone captivated

Team Leader, GR LANES

Excellent as always

QA Manager, PHE

Very useful, relevant and addressed key issues

QA Specialist, ACTAVIS BIOLOGICS

More fun than expected

Buyer, 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

Some recent reviews from our independently verified reviews.io site:

Find out about our course ranges

GMP Training

QMS Training

GDP/RP Training

GMP Compliance

QP Training

GDP Compliance

RSC approve the QA and Engineering versions of our highly effective online GMP course

Recent analysis of over 500 delegates who completed our online GMP courses in the last 6 months showed the course is very effective and with the approval from the RSC of our two new versions for QA and Engineering personnel this course is set to be of increasing value to Pharma organisations.

New live online interactive format a great success

All of our training courses are now being delivered using our ‘live online interactive” format. Making the transition away from classroom delivery has been challenging especially for the team delivering our highly successful and intensive 5-day Pharmaceutical GMP Lead Auditor course. But the reviews in this article show how we have risen to that challenge.

GMP course for Quality Assurance personnel

Our online GMP course for QA personnel is aimed at helping QA personnel to understand their role in helping their organisation to comply with the GMP regulations.

GMP for Engineers course

Following requests from several of our clients we have just released a new Chapter in our very popular GMP online course range aimed at Engineers.

Our most popular GMP and QMS articles

This article highlights some of our most popular articles

Does your organisational culture “get” data integrity and it’s importance?

 The MHRA’s GXP data integrity guide was published in March 2018. ‘GXP’ refers to the various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority...

The Golden Rules of GMP – a free GMP video

This free GMP video lasts less than 2 minutes and you can download it for your personal use OR as a part of any refresher/compliance training programme you are running in your organisation providing you leave the opening and closing credits part of the video.

Pharma supplier selection, approval and management

In this article we explore the controls needed to both approve Pharma suppliers and to control the purchasing of materials from them

GMP News and Articles

Read our articles on  GMP regulatory developments as well as news about our GMP training courses.

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:

2021

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.

Visit our Independent Reviews.io website