RP and RPI Training
Who is RP and RPI Training for?
Our RP training courses can be set for either one day or two days. It can be made suitable for both new as well as experienced RPs including regulatory and compliance personnel. It can cover the RPI process should it be relevant to your business model.
For RPs and personnel looking to update their knowledge, we also offer a one day intensive GDP RP Annual Refresher course which covers the latest GDP guidelines HMR 2012 and the updates to the Green Guide 2022.
The course is structured in line with the chapters from HMR 2012 with particular emphasis on the responsibilities of the RP and can be adapted to your specific business model.
RP & RPI Training Course
Relevant chapters and clauses will be discussed in sufficient depth taking into account the following at each stage:
1.
Rationale behind the guidance
2.
How to implement the guidance
3.
How to keep on top of your QMS
RP and RPI Training Course Contents
Topics covered will include:
- Supply Chain, Logistics and FMD
- Quality Management
- Quality system
- Management review and monitoring
- Quality risk management including Failure Mode and Effects Analysis
- Personnel
- Responsible Person
- Other personnel
- Training
- Premises and Equipment
- Premises
- Equipment
- Documentation and Control
- Operations
- Qualification of suppliers
- Qualification of customers
- Receipt of medicinal products
- Storage
- Destruction of obsolete goods
- Picking
- Supply
- Export to third countries
- Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
- Complaints
- Returned medicinal products
- Falsified medicinal products
- Medicinal product recalls
- Outsourced Activities
- Types of activities
- Service Provider audits and monitoring
- Technical Agreements
- Self-Inspections
- Audit planning
- Self-inspections
- Transportation
- Modes of transportation
- Containers, packaging and labeling
- Products requiring special conditions
- GDP Inspections and common deficiencies
- Summary of RP and RPI Roles and Responsibilities
The courses are interactive and include a variety of workshops to stimulate debate and bring real life situations into play.
Learning Objectives
By the end of this interactive course you will be able to:
- Describe the importance of Good Distribution Practice and why you need to comply
- Understand the latest UK GDP
- Understand and have a comprehensive knowledge of the Roles and Responsibilities of the Responsible Person in GDP
- Identify controls necessary to maintain compliance
Course Availability
Our RP Training is available throughout the year.
If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation, please contact us.
Interested in our RP and RPI Training?
Everything we do is tailored to the customer, contact us to see how we can help you with your training.
Flexible Training & Services
Our services and training can be tailored to your exact needs. We understand that within the pharmaceutical industry, there is no such thing as a ‘one size fits all’ solution to services such as RP & RPI Training.
Let us know your requirements and we can create the perfect, custom solution for you.