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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 InformationCourse Dates

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.

Key features 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:

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).

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Create a training plan

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

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.

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 in the industry.

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Cogent Gold Standard

Our Responsible Person training course includes all of the requirements of the Cogent Gold Standard for trainee RPs.

Make a Booking

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

2021

Venue for all dates: Your home or workplace using our proven ‘live online interactive’ courseware. From the list below select the date you want to make a booking (dates in blue are ‘Waiting List’ only):

Monday 24th to Wednesday 26th May 2021

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Tuesday 6th to Thursday 8th July 2021

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Tuesday 5th to Thursday 7th October 2021

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Booking details

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

Course cost

£1695  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.

What's included in cost

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.

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 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

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 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

Course 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 Details

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

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. 

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

  • Reasons for first, second and third party audits – using them effectively
  • How to plan, execute, report and close-out internal and external audits
  • Opening and closing meetings
  • Auditing Senior Management and their commitment to the system
  • How to perform audits professionally
  • Audit role-play exercise – with pharmaceutical facility video and over 300 documents and records to review
  • Auditing functions, departments and processes
  • Good auditing techniques
  • Checklist construction
  • Auditing for compliance to GMP
  • Getting to the root-cause of a problem
  • Adding value as an auditor
  • How to conduct audits that promote increased process performance
  • ISO 19011 guidelines for quality and management systems auditing

Live Online Interactive Training

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

Stay Safe - Attend from home or whilst at work

With 2 and sometimes 3 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.

Why choose Inspired Pharma?

Expert Tutors

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 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 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.

 

Recent independently verified delegate reviews:

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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:

2021

April

19 Pharma GMP Lead Auditor

26 Pharma GMP Lead Auditor

May

05 Sterile Products

11 Internal Auditor

17 Pharma GMP Lead Auditor

26 Responsible Person

erson

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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