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GMP Problem Solving 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

Attend this highly interactive one-day GMP Problem Solving course and you will leave with an understanding of how to use a wide range of problem-solving tools to solve problems that occur in a pharmaceutical environment, and also learn how to take steps to avoid these problems occurring in the first place.

Inadequately dealing with problems, not getting to the root-cause of a problem and not taking effective correction and corrective action are becoming THE major findings at regulatory inspections.  It is therefore critical that you deal with problems in a systematic, consistent, compliant and auditable way.

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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

We have decided to cancel all courses from now to the end of August. Hopefully the current travel and work restrictions will be eased by then. For anyone booking on our Autumn courses our normal cancellation terms will be relaxed just in case the restrictions return or, heaven forbid, are not relaxed in these timescales.

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.

Map

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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.

His in-depth knowledge of the requirements of Secondary Manufacturing and Packaging have been gained from close collaboration with QPs and other Quality functions whilst managing investigations into Quality Incidents.

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.

Matt has trained and coached at all levels within organisations and has a genuine passion for people and their development.

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

2020

Public schedule cancelled until end of August due to COVID-19

September

7 Pharma GMP Lead Auditor
15 Documentation and Records
16 Good Distribution Practice
21 Pharma GMP Lead Auditor London, UK 
22 Advanced GMP

October

06 Responsible Person
06  Data Integrity
12 Pharma GMP Lead Auditor Manchester, UK
20 Good Manufacturing Practice
21 Sterile Products

November

10 Internal Auditor
24 Problem Solving
30 Pharma GMP Lead Auditor

All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.

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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