Introduction to GDP

Introduction to GDP 993 1 2105 Add to basket - SEK 2 105
Try one modules

Introduction to GDP

Basic Level | Course | English | Pharma | 59 minutes

Corresponds to ½ day of teacher-directed learning

Description

In 2013, the EU requirements on Wholesale distribution and Good Distribution Practice was updated and published in Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01).

This training will give you an introduction to the requirements and a walk-through of the GDP Guide.

This training is suitable for companies with a Wholesale Dealer Authorisation both also other actors that needs to comply with GDP guidance, either party or as a whole.

Content

  • Background and regulatory requirements
  • The approval process and role of authorities
  • Quality management and Personell
  • Facilities
  • Equipment
  • Documentation
  • Operations
  • Complaints
  • Outsourced activities
  • Self-inspection
  • Transportation
  • About Brokers

Course modules

1. Background and regulatory requirementsTry it!

Here you will learn about the background to the existence of regulations, briefly about how the rules are structured and where to find the various directives, guide documents and guidelines.

Trainer: Anna Lundén
Duration: 8 minutes (Total duration of the course: 59 minutes)

2. Key elements of GDP

In this module we will have the first overview of the GDP Guide and then start the review of the first chapter, Quality Management.

Trainer: Anna Lundén
Duration: 5 minutes (Total duration of the course: 59 minutes)

3. Personnel

This part covers requirements related to personnel such as job descriptions, training and the specific requirements for the RP, Responsible Person.

Trainer: Anna Lundén
Duration: 6 minutes (Total duration of the course: 59 minutes)

4. Premises and equipment

Requirements related to facilities, including storage areas will be discussed here and also handling of medicinal products in the warehouse.

Trainer: Anna Lundén
Duration: 5 minutes (Total duration of the course: 59 minutes)

5. Premises and equipment, continued

This part contains additional information about cold storage and introduction to the terms qualification and validation.

Trainer: Anna Lundén
Duration: 7 minutes (Total duration of the course: 59 minutes)

6. Documentation

You will get introduced to the backbone of the quality system - instructions and records. We talk about document control and the importance of traceability.

Trainer: Anna Lundén
Duration: 3 minutes (Total duration of the course: 59 minutes)

7. Operations

In this part, we talk about requirement to qualify both suppliers and customers and also other activities, we need to control to prevent falsified products to enter the supply chain. You also get some insight in requirements related to the daily tasks in handling goods.

Trainer: Anna Lundén
Duration: 6 minutes (Total duration of the course: 59 minutes)

8. Complaints, returns and recalls

Here we go through the requirements for routines around this and when we need to make investigations. We also touch on the risks more about the risks of illegal products as complaints can be related to this.

Trainer: Anna Lundén
Duration: 4 minutes (Total duration of the course: 59 minutes)

9. Outsourced activities and Self-inspections

All activities that you outsource, you are still responsible for. Here we go through the requirements for contracts, supplier assessment and follow-up. We also briefly touch on the requirement to do an internal audit or self-inspection as it is called in the GDP guide.

Trainer: Anna Lundén
Duration: 6 minutes (Total duration of the course: 59 minutes)

10. Transportation

Here we talk in more detail about the requirements for transport, regardless of whether you do it yourself or if you hire someone else. We touch on risk assessment of transport routes and how to reduce the risks of quality deteriorating during transport.

Trainer: Anna Lundén
Duration: 6 minutes (Total duration of the course: 59 minutes)

11. Brokers

Here we talk about how some of the GDP requirements also affect Brokers and finally, you get some concluding words about the purpose of these requirements and patient protection as a key objective for the requirements.

Trainer: Anna Lundén
Duration: 3 minutes (Total duration of the course: 59 minutes)

Course material

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Notes

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Training organisation

Key2Compliance AB

Key2Compliance AB is an independent international organization providing its training and services to a variety of functions in the Life Science industry, from development to market in terms of Quality Systems and Regulatory compliance.

By helping organizations to comply with regulatory expectations, to enhance workforce knowledge and motivation and to promote a correct attitude towards quality, we believe we contribute to the supply of safe health care products - and in a wider perspective we save lives.

Trainer

Anna Lundén

Anna Lundén is one of the founders of Key2Compliance® and works in close contact with the Life Science industry with both training and consultancy. She has developed various training modules for many different levels of employees, from top management to line operators. She has long experience of working with European companies dealing with both EU and FDA requirements and expectations.

The course results in a diploma that shows that you have the skills required.

All prices shown exclude VAT.


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