This 3 day intensive Responsible Person training course is aimed at people who want to become a Responsible Person (RP) and is based on and includes the requirements of the Cogent Gold Standard for trainee RPs.
The course covers the roles and responsibilities of an RP to help ensure that the end user receives medicinal products that have been controlled, stored and transported correctly. The course includes the requirements of Good Distribution Practice (GDP) and the legal responsibilities of an organisation holding a Wholesale Dealers Authorisation (WDA) to ensure that products are purchased and sold within the legal supply chain. During the course we cover the specific requirements for the correct transportation, storage and distribution of medicinal products and well as the need to have a well designed Quality Management System (QMS) with a focus on compliance and continual improvement.
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Our 3-day Responsible Person training course is available on the following dates:
Tuesday 11th to Thursday 13th June 2019
Venue: Reading, Berkshire UK
Tuesday 15th – Thursday 17th October 2019
Venue: Reading, Berkshire UK
The cost of the Responsible Person 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 want to become a Responsible Person as well as individuals involved in the procurement and sale of bulk medicines, including Wholesale Dealers Authorisation holders. The course is also of value as part of Continuous Professional Development of existing RPs. In addition, the course will be of value to Qualified Persons (QP) who need a detailed appreciation of GDP and the role of an RP. The course is also of value to people who are involved in the selection of organisations involved in the storage and transport of finished products, as well as supplier auditors who audit such organisations
RP Course overview
This Responsible Person training course is presented over 3 days and is based on and includes the requirements of the Cogent Gold Standard for trainee RPs. This is a lively and highly interactive course with practical workshops and exercises throughout the programme. During the course delegates will create a training plan and gap analysis for themselves to ensure that, on completion of the course, they go on to gain the required knowledge and experience to satisfy the requirements of an RP. In addition delegates will have the opportunity to network with the course tutors and other delegates during events on the evenings of days 1 and 2.
A short online refresher/compliance GDP programme costing £95 per learner is also available – for more details click here.
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£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.
- Evening Drinks reception (optional)
- 1-2-1 optional meetings with tutors
- Full tutor support and access during course times.
Day 1: 09.00 – 16.45 Optional drinks reception with the tutors (17.30 – 19.00)
Day 2: 09.00 – 16.45 Optional 1-to-1 meetings with the tutors (17.30 – 19.00)
Day 3: 09.00 – 16.00
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]
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.
Click on map for larger scale:
Day 1: The roles and responsibilities of the Responsible Person (RP)
What is the RP?
- The legal responsibilities of the RP
- The availability of the RP and delegation rules and guidelines
- Interactions with Senior Management and the WDA holder
How do you become an RP?
- Skills and experience necessary to become an RP in the UK
- The Cogent Gold Standard
- Creating a Job Description and Objectives for an RP
- Creating individual training plans for RP personnel development
Law and Administration
- The European Medicines Agency (EMA) and EUDRAGMDP
- European Union (EU) Directives
- The MHRA and UK Regulations and Guidelines
- Wholesale Dealers Authorisations (WDA)
- The Good Distribution Practice (GDP) guidelines
- The legal status of medicines and their sale
- The Falsified Medicines Directive (FMD)
- Import and export of medicines
- Home Office licences and Control Drugs (CDs)
Evening drinks reception
- Networking event with tutors and fellow delegates (optional)
Day 2: Transportation, storage and distribution of medicinal products
- Transport options (road, rail, sea and air)
- Selection of suppliers
- Supply chain mapping/ route profile
- Specific requirements for road, sea and air
- Risk management during transportation
- Operations and activities at ports and airports
- Customs, export documentation and tariffs
- Control and monitoring of transport conditions
- Facility design and operation
- Different storage conditions for products
- Temperature and environmental control
- Dealing with temperature excursions
- Thermal mapping of facilities
- Equipment selection
- Validation, Qualification and Calibration of premises and equipment
- Control of goods-in and goods-out
- Goods-in and receipt of materials
- Inspection of incoming materials
- Pest control and cleaning
- Use of computer-based stock control systems
- Picking and packing of materials
- Issue and despatch of materials
- Control of returns, rejected and quarantined materials
- Supply chain integrity
- The Falsified Medicines Directive (FMD)
- Use of brokers and freight-forwarders
Evening 1-to-1 tutor meetings
- Speak to tutors in private regarding any specific concerns or queries (optional)
Day 3: Ensuring compliance and continual improvement
Quality Management Systems (QMS) design
- Monitoring and managing a QMS
- Documentation and records
- Dealing with Complaints and Recalls
- Correction, Corrective Action and Preventive Actions (CAPAs)
- Problem solving and root-cause analysis
- Change control
- Management Review
- Quality objectives and key performance indicators
- The self-inspection/ internal audit mechanism
- The importance of having clearly defined roles and responsibilities
- The importance of training and evaluation
- Improvement of a QMS
Supply Chain Management
- Supplier selection
- The definition of a “supplier”
- Qualification of suppliers (bona fides)
- Customer selection
- The definition of a “customer”
- Supply chain mapping and risk evaluation
- Business continuity plans
Outsourcing of activities
- Subcontractor selection and monitoring
- Auditing of suppliers
Why choose Inspired Pharma?
Christine started her career with Sanofi Winthrop working in QC over 20 year’s ago, moving through to the QA Department and from there into QP training as her career progressed, finally working as Head of Quality. She has extensive experience of working in both ethical and generic pharmaceutical companies and with a wide range of dosage forms. She is eligible to work both as a Qualified Person (QP) and a Responsible Person (RP), having extensive GMP and GDP experience internationally.
Pelleren has over 30 years’ experience of UK and international logistics and supply chain management within many industries, in particular pharmaceutical (both human and veterinary). He brings common sense and pragmatic solutions to all aspects of the distribution of medicines.
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.
Unique 3-day format
We believe that investing 3 days of your time on this Responsible Person training course will confidently set you on a path to become a Responsible Person in a much shorter timeframe than by attending other less in-depth and less interactive 2-day courses.
Some Important and unique features of the 3-day Responsible Person training course include:
- During the course delegates will create a training plan and gap analysis for themselves to ensure that, on completion of the course, they go on to gain the required knowledge and experience to satisfy the requirements of an RP
- 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
- 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
- The 3-day format means this is a lively and highly interactive course with practical workshops and exercises throughout the programme.
- For maximum interactivity, our class size is limited to 12 delegates with at least two tutors if there are more than 6 delegates on the course
- The Responsible Person training course includes all of the requirements of the Cogent Gold Standard for trainee RPs
From our range of RP/GDP courses
This was a great course that met my needs to get trained in GDP. There were lots of practical examples to test learning during the course
We all found this course very accessible and easy to follow. It has been a great help to our Company
Very good knowledgeable tutor, enthusiastic and approachable
Really well presented with a great mix of slides and exercises
Our most recent independently verified reviews from the Reviews.io website
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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
13 Pharma GMP Lead Auditor Central London, UK
24 Pharma GMP Lead Auditor Dublin, Ireland
All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.
For all 2019 dates select the green 'See all Courses and Dates' button above or to the left.
Online courses available anytime anywhere
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?