For course details click on the subject areas shown in menu below. To contact us: +44 1635 866699 info@inspiredpharma.com

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.

Training to inspire you

Our courses receive fantastic reviews. Some ‘nuggets’ from our reviews.io website are shown opposite/below. Use the chevrons under the ‘nugget’ to navigate all of them. See the full quotes further down this page.

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

This course is available for in-house presentation, either on-site or virtually.  Please contact us for further details.

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.

Academy Skills Library

When a delegate completes their Course Feedback form they will be offered  free unlimited access to nearly 400 self-paced online courses for 3 months. For more details select the icon.

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:

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 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.

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

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Annex 1 2022 Section 10: Quality Control (QC)

This final article looks at the new requirements in section 10 on Quality Control. It is also a useful point at which to reflect on the 2022 version of annex and what might it mean.

Annex 1 2022 Section 9: Environmental and Process Monitoring

This article is covering section 9 which describes the annex 1 guidance for Environmental and Process Monitoring. Section 9 is now a centralized location for monitoring activities.

Annex 1 2022 Section 8: Production and Specific Technologies – part 3

In this final part of the article on section 8 we will look at Sterilization processes. The selection of a sterilization process should be based on scientific principles.

Annex 1 2022 Section 8: Production and Specific Technologies – part 2

This is the second part of the article covering section 8 of Annex 1 2022 and here we are looking at the requirements around Form fill seal and Blow fill seal.

Annex 1 2022 Section 8: Production and Specific Technologies – part 1

This next article in our series is about section 8, which is the largest section of Annex 1 and covers production and specific technologies

Annex 1 2022 Section 7: Personnel

In this article, we move onto the personnel section, section 7.

Annex 1 2022 Section 6: Utilities

In this article we expand upon the equipment section but looking at Utilities as described in section 6.

Annex 1 2022 Section 5: Equipment

In this article we look at the general requirements for the equipment used in the manufacturing of sterile products.

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:

Our Public Course range

Most of our public courses are currently 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. In 2022 we began to once again offer traditional classroom courses - see details on each course page.

Click on course name for full course details and dates:

Pharmaceutical GMP Auditor/Lead Auditor

Advanced Good Manufacturing Practice

Good Distribution Practice

Good Manufacturing Practice

Internal Auditor

GMP Problem Solving

Responsible Person (RP)

Sterile Products

Webinar: Microbiological control in pharmaceutical production 

QP Courses - full range

See and download our Auditing Brochure detailing our courses and services in this important area.

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