91AV

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 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.

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.  

Day 1: The roles and responsibilities of the Responsible Person (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

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 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