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Advanced Good Manufacturing Practice Training Course

A 3-day intensive RSC Approved Advanced GMP training course for people wanting an in-depth appreciation of GMP 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 will also offer traditional classroom courses - see details below.
Key InformationMake Booking

Our intensive 3-day Advanced GMP Training Course is aimed at people who need an 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 UK and 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.

Key features of our 3-day course

    Certificate with RSC Approved Training logo

    Every learner who completes the course can download a Certificate with our logo and the RSC Approved Training logo  

    Online Data Integrity course RSC logo

    Network events with tutors and delegates

    Delegates will have the opportunity to network with the course tutors and other delegates on the evenings of days 1 and 2 including optional 1-2-1 meetings with the tutors (either online or face to face).

    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.

    Lively and highly interactive course

    Our 3-day 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.

    Help to deliver competitive advantage

    Most of day 3 looks at the importance of a well-designed Quality Management System in ensuring your organisation meets regulatory expectations and outlines how to continually improve your QMS to deliver competitive advantage for your organisation.

    Make a Booking

    The dates for the course should appear above this text. If there are no dates please refresh this screen. This normally sorts out this little glitch (which we hope to fix shortly). If the dates still do not appear then visit this page and book from there.

    IN HOUSE COURSES - this course can also be delivered on your site or using our 'live online interactive' courseware on a date to suit you. If required we can customise the course and/or run over several sessions. If you are interested please contact us at  [email protected] .

    Booking details

    Select the tabs below to find out all the details you need to know to make a booking:

    Course cost

    The cost of the Advanced Good Manufacturing Practice training course is £1995 plus VAT. Course will be charged in GB pounds. For full details of what is included in the cost see below.

    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 with RSC Approved Training logo.
    • Full tutor support and access during course times.

    Plus on Classroom courses refreshments and lunch are provided during course times.

    Not Included on Classroom courses: Accommodation costs – which need to be booked directly with the hotel – see venue details.

    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 Advanced GMP 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.

    Classroom Venues and Live Online

    Due to the uncertainties involved in travel at the moment most of our public courses are being delivered using our proven ‘live online interactive’ technology. Delegate feedback from these courses has been just as positive as our classroom courses and in addition, many people have enjoyed not having to travel in these difficult times. In 2022 we are looking to also offer traditional classroom courses – see the Course Dates panel for details. For venue and accommodation cost details click here. 

    N.B we reserve the option to switch our classroom courses to our ‘liveonline interactive’ format if this is no longer a viable and safe delivery method.

    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?

    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.

    So that we can give the delegates the right amount of time and attention – we limit this course to a maximum of 10 delegates.

    Course Times:

    Online Times:

    Day 1:            09.00 – 17.00 Optional informal live online event with tutors and delegates (17.30 – 19.00)

    Day 2:            09.00 – 17.00 Optional 1-to-1 live online meetings with the tutors (17.30 – 19.00)

    Day 3:            09.00 – 17.00 

    Classroom Times:

    Day 1 09.00 – 17.00 Optional drinks reception with the tutors 17.30 to 19.00
    Day 2 09.00 – 17.00
    Optional 1 to 1 meetings with the tutors 17.30 to 19.00
    Day 3 09.00  – 16.30

    Online Data Integrity course RSC logo

    Course Details

    Click on the tabs below for more details on the content of the course:

    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. 

    Day 1: The reasons for GMP and GMP in facility design

    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

    Networking event

    • Informal online networking event with tutors and fellow delegates (optional)

    Day 2: GMP in practice – incoming materials to product release

    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

    Evening 1-to-1 tutor meetings

    • Speak to tutors in private online meeting regarding any specific concerns or queries (optional)

    Day 3: GMP and the Quality Management System

    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 Management System

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

    Live Online Interactive Training

    This course is currently available using our proven and very popular ‘live online interactive’ format. Select the tabs below to find out more:

    Stay Safe - Attend from home or whilst at work

    With 2 expert facilitators and a maximum of 10 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 reducing any risks of COVID-19 and saving you a lot of time, hassle and money.

     As always we will ensure this event is inspirational, enjoyable and educational. 

    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.

    Traditional Classroom courses in 2022

    For those of you who would prefer to attend a traditional Classroom course we plan to offer this option in 2022 – see the ‘Course Dates’ panel for availability

    Why choose Inspired Pharma?

    Expert Tutors

    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.

    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.

    Recent Delegate feedback

    RSC Approved Training Course

    Certificate with RSC Approved Training logo

    Every learner who completes the course can download a Certificate with our logo and the RSC Approved Training logo 

     

    Online Data Integrity course RSC logo

    Find out about our course ranges

    GMP Training

    QMS Training

    GDP/RP Training

    GMP Compliance

    QP Training

    GDP Compliance

    RSC approve the QA and Engineering versions of our highly effective online GMP course

    Recent analysis of over 500 delegates who completed our online GMP courses in the last 6 months showed the course is very effective and with the approval from the RSC of our two new versions for QA and Engineering personnel this course is set to be of increasing value to Pharma organisations.

    New live online interactive format a great success

    All of our training courses are now being delivered using our ‘live online interactive” format. Making the transition away from classroom delivery has been challenging especially for the team delivering our highly successful and intensive 5-day Pharmaceutical GMP Lead Auditor course. But the reviews in this article show how we have risen to that challenge.

    GMP course for Quality Assurance personnel

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    GMP for Engineers course

    Following requests from several of our clients we have just released a new Chapter in our very popular GMP online course range aimed at Engineers.

    Our most popular GMP and QMS articles

    This article highlights some of our most popular articles

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    The Golden Rules of GMP – a free GMP video

    This free GMP video lasts less than 2 minutes and you can download it for your personal use OR as a part of any refresher/compliance training programme you are running in your organisation providing you leave the opening and closing credits part of the video.

    Pharma supplier selection, approval and management

    In this article we explore the controls needed to both approve Pharma suppliers and to control the purchasing of materials from them

    GMP News and Articles

    Read our articles on  GMP regulatory developments as well as news about our  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 will also begin to offer some 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

    Data Integrity

    Documentation and Records in GMP

    Good Distribution Practice

    Good Manufacturing Practice

    Internal Auditor

    GMP Problem Solving

    Responsible Person (RP)

    Sterile Products

    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