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 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 2-day GMP Problem Solving training course is available on the following dates:
Tuesday 24th November 2020
Venue: Reading, Berkshire UK
Coronavirus Update
With the easing of restrictions we are pleased to announce that our classroom courses will start running again from September 2020. To comply with social distancing class sizes have been reduced to a maximum 8 or 9 delegates dependent on the room size.
Stop Press: We are holding a number of instructor-led virtual courses in July. NOW SOLD OUT!
All Dates:
The cost is £695 plus VAT. Course will be charged in GB pounds. The cost of accommodation is not included in the course cost. For full details of what is included in the cost see below. To find out more about the venue select the link in blue in this sentence.
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.
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.
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.
Times:
Day 1 09.00 – 16.30
Venue details
Reading, Berkshire, UK
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 £123 (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.
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Why choose Inspired Pharma?
Expert Tutor
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 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
Very useful, relevant and addressed key issues
More fun than expected
Excellent as always
Kept everyone captivated
Excellent materials – the time flew by
A good introduction to the subject. Excellent – well delivered and great content
Find out about our course ranges
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QMS Training
GDP/RP Training
GMP Compliance
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GDP Compliance
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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.
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Forthcoming Public Courses
2020
Our classroom courses will be available from September
September
21 Pharma GMP Lead Auditor London, UK
29 Advanced GMP
October
12 Pharma GMP Lead Auditor Manchester, UK
20 Good Manufacturing Practice
November
All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.
Online courses available anytime anywhere
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.
To try a free taster of these courses to see if they are of interest visit this page.