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Advanced Pharmaceutical GMP Training Course

A 3-day intensive RSC Approved Advanced Pharmaceutical GMP training course for people wanting an in-depth appreciation of Pharmaceutical 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.
Key InformationMake Booking

Pharmaceutical Our 3-day Advanced Pharmaceutical 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 Pharmaceutical 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 Pharmaceutical GMP and how to apply these in the workplace.

Key features of our 3-day Pharmacetical GMP 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

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.

Training to inspire you

Our courses receive fantastic reviews. Some ‘nuggets’ from our reviews.io website are shown opposite/below. Use the chevrons under the ‘nugget’ to navigate all of them. See the full quotes further down this page.

Make a Booking

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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 you are interested please contact us at  info@inspiredpharma.com . To see our full range of in-house courses and customisation and delivery method options please visit this page.

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.

Academy Skills Library

When a delegate completes their Course Feedback form they will be offered  free unlimited access to nearly 400 self-paced online courses for 6 months. For more details select the icon.

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 Advanced Pharmaceutical GMP course benefit?

This Pharmaceutical GMP training 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 Pharmaceutical GMP training 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

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

Documents required by EU GMP

The list below details the documented procedures specified as being required by EU GMP. It is worth pointing out that many times in GMP there is a requirement to have a “procedure”, but this is not the same as a “documented procedure”.

GMP Calibration

Around a pharmaceutical manufacturing site there will be many measuring devices that require calibration. GMP requires the calibration of such devices with similar requirements in both EU and USA GMP

Dealing with problems – for good

Problems happen in work and in life.  Problems also happen within any quality system. GMP requires problems to be dealt with correctly.

CAPA – time for a rethink?

Most manufacturing sites these days have CAPA systems – a mechanism to capture, record, control and approve or reject Corrective Actions. However despite this approach many organisations feel that they are still in “fire-fighting” mode – always dealing with yesterday’s problems rather than preventing future issues from occurring.

ISO 9001 versus GMP – Part 2

One of the main problems of comparing GMP and ISO is that the two standards are not the same and are not really trying to do the same thing. This article highlights the key differences.

ISO 9001 versus GMP – Part 1

ISO 9001 versus GMP – this article lists the clauses of ISO 9001:2015 identifying requirements of ISO that are not specifically mentioned in EU GMP

Quality Assurance or Quality Control?

Quality Assurance or Quality Control? This article outlines the importance of these functions and areas where there may be some overlap.

Basic audit findings and EU GMP clauses

This article lists a number of common basic audit findings and the corresponding clause in EU GMP that is relevant. Readers should note that there is often some repetition in GMP, so I have tried to find the best single clause.

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.

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