Pharma Experts RP Training is a fully comprehensive two day training event suitable for both new and experienced RP’s including regulatory and compliance personnel.
For RP’s and personnel looking to update their knowledge we also offer a one day intensive GDP RP Annual Refresher course which covers the latest Good Distribution Guidelines EU 2013/C 343/01.
RP Training Course Contents
The course is structured in line with the chapters from the Good Practice Guidelines EU 2013/C 343/01 with particular emphasis on the responsibilities of the RP.
Relevant chapters and clauses will be discussed in sufficient depth taking into account the following at each stage:
- Rationale behind the guidance
- Risks and benefits associated
- What implementation looks like?
- Roles and Responsibilities of the RP
Topics covered will include:
- Supply Chain Fragmentation and Falsified Medicines
- Quality Management
- Quality system
- Management review and monitoring
- Quality risk management including Failure Mode and Effects Analysis
- Responsible person
- Other personnel
- Premises and Equipment
- Documentation and Control
- Qualification of suppliers
- Qualification of customers
- Receipt of medicinal products
- Destruction of obsolete goods
- Export to third countries
- Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
- Returned medicinal products
- Falsified medicinal products
- Medicinal product recalls
- Outsourced Activities
- Types of activities
- Service Provider Audits and Monitoring
- Technical Agreements
- Audit Planning
- Modes of Transportation
- Containers, packaging and labelling
- Products requiring special conditions
- GDP Inspections and Common Deficiencies
- Summary of RP Roles and Responsibilities
The courses are interactive and include a variety workshops to stimulate debate and bring real life situations into play.
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 Good Distribution Guidelines EU 2013/C 343/01
- Understand and have a comprehensive knowledge of the Roles and Responsibilities of the Responsible Person in GDP
- Identify controls necessary to maintain compliance
The RP Training course is available throughout the year.
The Training Calendar is updates regularly and lists training events which may be of interest to you.
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 our office and send us your request, or schedule a free initial telephone consultation.