+44 1635 866699 [email protected]

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 two-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 27th November to Wednesday 28th November 2018

Venue: Reading, Berkshire UK

Thursday 6th June to Friday 7th June 2019

Venue: Reading, Berkshire UK

Tuesday 26th to Wednesday 27th November 2019

Venue: Reading, Berkshire UK

All Dates:

The cost is £1190 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.

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
  • The new GMP Chapter 1 and Chapter 8 requirements for Problem Solving
  • 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
  • Continual improvement mechanisms
  • Managing deviations and outstanding actions
  • The role of Senior Management with Problem Solving
  • 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:

£1190  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 Day 2 09.00 – 16.00

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 £121 (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

Peter Lavis

Arguably the finest Quality Management Systems tutor in the business, Peter’s enthusiasm for quality system thinking and his outstanding training abilities have gained him international praise and appeal. Peter is a leading quality management systems auditor and encourages auditors to think outside the “GMP box”.

Dominic Parry

Dominic Parry has worked in the pharmaceutical industry since 1992, and is a leading pharmaceutical quality management specialist. 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.

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 thanexpected

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 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.

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Forthcoming Public Courses

September

10 Pharma GMP Lead Auditor

October

09 Data Integrity
10 Good Distribution Practice
17 Good Manufacturing Practice

November

05 Pharma GMP Lead Auditor Manchester, UK
13 Internal Auditor
20 Sterile Products
27 Problem Solving

December

03 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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