Prabjeet Dulai, GDP & Quality Matters
Dr Martin Egger, Pharmaserv
Dr Afshin Hosseiny, Chair of the European GDP Association
Dr Daniel Müller, GMP/GDP Inspector
Dr Laura Ribeiro, OCP Portugal
The EU GDP Guidelines require that wholesale distributors have to appoint a Responsible Person (RP) for GDP. There has been a lot of discussion about the duties of the RP. Therefore, the ECA Foundation’s GDP Working Group has developed this training course. In this course, the role and responsibilities of the Responsible Person for GDP will be highlighted and discussed.
In 2013 the new ‘Guidelines on Good Distribution Practice of Medicinal Products for Human Use’ were published. The Guidelines were revised to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union. Moreover, it should take into account the amendments to the Community Code which have been introduced with Directive 2011/62/EU of the European Parliament and of the Council. It is amending Directive 2001/83/EC on the Community code relating to medicinal products for human use with regard to preventing falsified medicinal products to enter the legal supply chain.
In Chapter 2 “Personnel”, tasks and responsibilities of the RP are defined. RPs should fulfil their responsibilities personally and should be continuously contactable. The RP may delegate duties but not responsibilities. General requirements like organisational chart, job descriptions and training requirements are new or outlined in much more detail.
This Live Online Training is of particular interest to Responsible Persons but also management and quality personnel from pharmaceutical companies, wholesalers, distributors and service providers involved in distribution of medicinal products for human use.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme Day 1
Welcome and Introduction
The EU GDP Guidelines
- The counterfeit directive and the introduction of the EU GDP Guidelines
- GDP requirements for the pharmaceutical supply chain
- Regulatory expectations for implementation
- Inspections of the competent authorities
Roles and Responsibilities of the Responsible Person
- Qualifications requirements for RPs
- Duties and Delegation
- How to discharge your duties
- What the Responsible Person (RP) needs to know about batch release
Experiences from GMDP Inspections
- Frequent Findings
- Expectations with regard to the Responsible Person
The Role of the Responsible Person in Management of Export and Import to and from UK
- What does batch release mean?
- Responsible Person (RP) vs. Qualified Person (QP)
- Brexit and its impact on supply chain
- Export and import to and from UK
- How does RP discharge its responsibilities post Brexit
The Roles and Responsibilities of Wholesalers and 3PL Service Providers
- Services offered
- How to manage different clients and their requirements
- Pick and pack – best practices
- How to stay in compliance
- How to plan the audit
- Approach to GDP audits
- Reporting deficiencies
- Examples of recent audit findings
Final Discussion Day 1
What you need to know about 3PL Service Providers
- How 3PL service providers are organised
- Contracts and qualification
Case Study: Management of a GMP warehouse and distribution of medicinal products with a 3PL-Approach
- Outsourcing in Pharma Logistics – current trends & benefits
- Determining the scope of Outsourcing
- Processes, roles & responsibilities
- Monitoring of critical data
- Reporting of the performance & controlling of the 3PL
Roles and Responsibilities of an RP and a QP
- Responsible Person vs. Qualified Person
- GDP vs. GMP
- Product finishing activities
- Product diversions
- Handling of returned and damaged goods
- Complaint Handling
Controlled Temperature Distribution
- How to manage cold chain products
- How to manage 15 – 25 °C requirements
- Air freight, sea freight, road transport and the last mile
Security in the Supply Chain – what is expected and how Industry is approaching it
- Track and Trace
- Recent developments
- How can track and trace support anti-counterfeiting requirements
- Current technologies
Final Discussion Day 2
Recording from 24.03.2021
Duration of recording: approx. 10,5 h