+44 1635 866699 [email protected]

Advanced Good Manufacturing Practice Training Course

A 3-day intensive Advanced GMP training course for people wanting an in-depth appreciation of GMP
Key InformationWhy Inspired

Our intensive 3-day Advanced GMP Training Course is aimed at people who need a in-depth appreciation of the requirements of Good Manufacturing Practice (GMP).

The course covers the need for and history of GMP as well as the key GMP requirements at the various parts of a pharmaceutical manufacturing site, from goods-in to despatch of the finished product. The Advanced GMP training course is based on the requirements of European Union (EU) GMP, with comparison of this to other GMPs also provided. Delegates will leave the course with a very  clear and well rounded application of the requirements of GMP and how to apply these in the workplace.

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If you would like a hardcopy of the Advanced GMP training course details then select the button opposite (or below on a phone)

Make a Booking

Our 3-day Advanced GMP training course is available on the following dates:

Tuesday 2nd - Thursday 4th April 2019

Venue: Reading, Berkshire UK

Tuesday 22nd to Thursday 24th October 2019

Venue: Reading, Berkshire UK

All Dates:

The cost of the Advanced Good Manufacturing Practice training course is £1950 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 RP training 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?

This course is aimed at people who work in Quality Assurance, Quality Control and Production personnel who need a greater appreciation of GMP than is often offered via traditional in-house GMP awareness training courses. The course is aimed at team leader and junior management level and is used as a development course for people who are to be managers of the future. The course is ideal for people who are new to the pharmaceutical industry and are in a role where a very good working knowledge of GMP is essential.

Advanced GMP Training Course overview

This course is presented over 3 days and provides a real depth of information on the main aspects of pharmaceutical GMP. During  the course the main GMP requirements for purchasing, goods-in, the warehouse, production, packaging, Quality Control and batch release are covered. In addition, the course also covers the main elements of the Quality Management System needed to provided medicines of the highest quality, including the requirements for documentation, training and system monitoring and review. The course is full of interactive exercises and workshops throughout the programme.

We also offer a 1-day course for those people who need more of an overview of GMP – for details click here.

And in addition, we offer a short online refresher and/or compliance GMP programme costing  £95 per learner – for more details click here. 

Why not subsribe to our mailing list to try a free Taster  of these courses to see if they are of interest?

Course cost:

£1950  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 – 17.00  

Day 2:            09.00 – 17.00

Day 3:            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 £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.

Map

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Course Contents

Day 1: The reasons for GMP and GMP in facility design
Day 2: GMP in practice – incoming materials to product release
Day 3: GMP and the Quality Management System

Why do we have GMP?

  • The history of GMP
  • Why do we have GMP?
  • Approval of medicines and manufacturers

GMP – rules and guidelines

  • European Union (EU) GMP and the EU Guide to GMP
  • GMP in the United States
  • Other GMPs from around the world

Premises and facility design

  • Suitable premises and facility design
  • Heating, Ventilation and Air-Conditioning systems
  • Access, security and pest control

Equipment, maintenance and calibration

  • Selection of equipment and installation
  • Planned Preventive Maintenance (PPM)
  • Calibration of measuring equipment

Validation, qualification and change control

  • The differences between validation and qualification
  • The different stages of validation
  • The importance of controlling changes

Water systems

  • The different types of water
  • Water system design, construction and monitoring

Purchasing, incoming materials, suppliers and outsourced activities

  • GMP requirements for incoming materials
  • Supplier selection and control
  • Control of outsourced activities

The warehouse

  • Control of incoming materials
  • Storage of materials
  • Issue of materials to production
  • Control of rejected and returned materials

Manufacturing

  • Different types of dosage forms
  • Initial checks of the area, equipment and materials
  • Documentation and records
  • Reporting of problems
  • Cleaning of the equipment and area

Packaging

  • Packaging equipment design and facility layout
  • Control of materials and product
  • Overprinting of artwork

Quality Control

  • Good Control Laboratory Practice
  • Test specifications and pharmacopoeias
  • Analytical method validation and method transfer
  • Recording of results and release of materials
  • Ongoing stability storage and testing

People and training

  • Organisation charts, job descriptions and training records
  • GMP, hygiene and job specific training
  • Training design and evaluation

Key personnel in GMP

  • The Heads of Production, QC and the Qualified Person
  • The role of Quality and Quality Assurance
  • The importance of Senior Management

Documentation, records and data integrity

  • Control and approval of documents and records
  • Data Integrity and regulatory concerns
  • The use of computer systems

Quality Risk Management

  • The need to make decisions based on risk
  • ICH Q9 and its requirements
  • Reactive and proactive risk assessments

Deviations, incidents and complaints

  • CAPA systems – good and bad points
  • Problem-solving and root-cause analysis
  • Dealing with complaints effectively

Specific GMP requirements for certain types of products

  • Sterile products manufacturing
  • Biological products
  • Advanced Therapy Medicinal Products

The Quality Mannagement System

  • Batch review and release
  • Product Quality Review
  • Internal auditing
  • Management review
  • Continual improvement
  • The requirements of ICH Q10

    Why choose Inspired Pharma?

    Expert Tutors

    Delegate Feedback

    Recent feedback from delegates attending our range of GMP courses

    Andy Martin

    Andy Martin

    Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew.  Following this he had a number of roles culminating when he took over as QA Microbiology Manager.   In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions.  Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

    Matt Morris

    Matt Morris

    Acknowledged and admired as a highly focused and committed consultant and coach, Matt is a dynamic, energetic and authentic trainer who demonstrates his passion and communicates this to all who encounter him.  With 19 years pharmaceutical experience, mostly with GlaxoSmithKline, he has extensive knowledge of GMP gained from his years in Packaging, Logistics and QC and draws on his experiences to create a lively, relevant training environment.

    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.  Matt has trained and coached at all levels within organisations and has a real passion for training. 

    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.

    Dominic was outstanding

    Site Head, NOVARTIS

    Excellent materials delivered in a digestable format 

    Team Leader, SOURCE BIOSCIENCE

    An excellent course

    QA Officer, TEVA

    Well presented and interesting

    Director of Clinical Operations, TAKEDA

    Very knowledgeable and eye opening

    Team Leader, AESICA

    Fantastic – kept everyone interested and engaged

    QA Manager, ESCUBED PHARMA

    Recent independently verified reviews about our range of GMP courses from Review.io

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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

    2019

    January

    21 Pharma GMP Lead Auditor

    Febuary 
    12 Data Integrity

    March

    Pharma GMP Lead Auditor Osaka, Japan
    13 GMP Documentation and Records
    14 Good Manufacturing Practice
    18 Pharma GMP Lead Auditor
    26 Responsible Person

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

    For 2019 dates select the green 'See all Courses and Dates' button above or to the left.

    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.

    Why not subcsribe to our mailing list to try a free Taster  of these courses to see if they are of interest?

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