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.

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 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.

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.

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.

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 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)

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)

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

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 saving you a lot of time, hassle and money.

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

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.