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Responsible Person/RP training course

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. This course will be 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 InformationWhy Inspired

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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Make a Booking

Our 3-day Responsible Person training course is available on the following dates:

Tuesday 8th to Thursday 10th December 2020

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

Tuesday 26th to Thursday 28th January 2021

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

Tuesday 20th to Thursday 22nd April 2021

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

Tuesday 6th to Thursday 8th July 2021

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

Tuesday 5th to Thursday 7th October 2021

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

All Dates:

The cost of the Responsible Person training course is £1950 plus VAT.

Course will be charged in GB pounds. For full details of what is included in the cost see below.

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.

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.

Coronavirus Update

Due to the uncertainties involved in travel at the moment we will be delivering all of our public courses using our proven 'live online interactive' technology. Delegate feedback from the courses we delivered in June and July has been just as positive as our classroom courses and in addition, many people have enjoyed not having to travel in these difficult times.

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. 

Why not subscribe 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.

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.
  • Full tutor support and access during course times.

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

Course Contents

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)

Networking event

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

Day 2: Transportation, storage and distribution of medicinal products

Transportation

  • 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

Storage

  • 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

Distribution

  • 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 online meeting 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

Live Online Interactive Training

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. See the feedback below:

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.

I found the interaction very good by using the chat option as it keeps everyone interested and there was a variety of questions and answers.

Quality / EHS Specialist, DCC VITAL

Great course, although it was virtual I felt we got the same value for money as if it was F2F, a 10 out of 10!!! I will recommend to colleagues

Quality Executive, ABPI

The GMP course was ran very well. Both presenters were very knowledgeable in the area, both for the EU and other countries. I would highly recommend this course to those who are new to the area of GMP, as well as those who just need a bit of a refresher.

 

Training Officer, THORNTON & ROSS

Why choose Inspired Pharma?

Expert Tutors

Christine Morris

Christine Morris

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.

Sarah Pratt

Sarah is a pharmacist with a masters in drug development.  Her career history includes senior and international roles with Sanofi, AstraZeneca and C-suite, managerial and consultancy roles across a number of smaller international innovator and contract organisations in the UK, France and Belgium.  Sarah’s major areas of expertise lie within the GDP and GMP arena within both pharmaceutical development and within commercial manufacture/supply chain sectors and she has held the position of Responsible Person on European wholesale dealers’ authorisations.  She also runs a masters module at Queen Mary University in London on Regulation within the Pharmaceutical Industry.

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.

Key benefits of our 3-day course

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 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 10 delegates with at least two tutors 
  • The Responsible Person training course includes all of the requirements of the Cogent Gold Standard for trainee RPs

Delegate Feedback

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

Director Regulatory & Medical Affairs, INFIRST HEALTHCARE

Really well presented with a great mix of slides and exercises

QA Manager, Sanofi

Our most recent independently verified reviews for this course 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.

Quick Links

Find your way quickly to any  part of our website by selecting any of the links in this section:

Forthcoming Public Courses

All of our public courses are 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.

Click on course name for full details:

2020

October

20 Good Manufacturing Practice

21 Sterile Products 

29 Data Integrity 

November

10 Internal Auditor

16 Pharma GMP Lead Auditor

24 Problem Solving

30 Pharma GMP Lead Auditor

December

08 Responsible Person

14 Pharma GMP Lead Auditor

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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