Compliance Seminars®

Good Distribution Practice
- A Practical Approach

This course is designed specifically for staff working in wholesale and distribution of medicines. It will assist them in understanding and applying Good Distribution Practice principles to practical workplace situations.


Course description:

The development of the rules and guidelines of GDP will be discussed with the delegates, who will then go on to investigate the implications, potential risks to product safety and the control systems in place within their organization. By relating these findings back to the organization’s quality system, the delegates discover how quality is an integral part of their business.

The course includes a significant number of practical exercises, case-studies and workshops to allow delegates to investigate real situations and develop practical solutions.

Delegates will be encouraged to share personal experiences and solutions to the various challenges faced in everyday work.

Who should attend:

The course is aimed at anyone who has responsibility for finished pharmaceutical products, intermediates or raw materials during storage and distribution – including transportation.  This will include staff working in Quality, Operations, Transportation etc.

Course outline:

  • Regulations and guidance
  • The Quality System
  • Risk management
  • The responsible person
  • Self inspection
  • The inspection process
  • Facility management
  • Stock management
  • Temperature control and monitoring
  • Transport – including Cold Chain
  • Counterfeit medicinal products

Learning objectives:

The objectives of the course are that delegates will understand the regulatory requirements and constraints facing wholesalers and distributors of medicinal products. The attendees will become familiar with the relevant sections and clauses of the EU Rules, as well as being able to develop their organization’s process and identify the controls necessary to ensure compliance with GMP/GDP regulations and guidelines and, at the same time, operate effectively in a competitive market.

Gate2GMP®

When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »

 

Bring this course in-house?

Are you a group in need of the same training?
Do you wish to customize this course to suit your needs?

 If so, running the course in-house is probably the best and most cost effective solution.

Make an enquiry

 

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Course facts

Course no:
5222
Industry:
Medicinal/Pharmaceutical industry; storage and distribution of pharmaceutical products including raw materials (excipients and APIs), intermediates and final dosage forms.

Level:
Basic / Intermediate
GMP region:
EU and US

Language:
English
Instructor:

Mr Robert J. Hayes

Date, location and venue:

12-13 June 2018, Copenhagen Denmark
DGI-byen
Tietgensgade 65    
(Entrance from Kvægtorvsgade)

Specify our booking code D000030870 to get a discount when making a reservation at a Scandic Hotel.
Scandic Hotels nearby:
» Scandic Webers (500m)
» Scandic Copenhagen (800m)

This course is also offered in-house.
Click here for more info and inquiry form.


Time:
2 days
8.30-16.30 (Registration 08.00-08.30, day 1)

Price (excl. local VAT):
€ 1925 incl. course material (pdf), lunches and refreshments
Note. Accommodation is NOT included in the course fee.

Discounts:
For groups registered and invoiced together we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
We do not offer or practice any general company discounts without commitments and/or written agreements.

Course material (Handouts)  
No printed course material will be provided on our courses*.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
* If you still want a printed course handouts binder from us, we charge 50 Euro/pcs (of which 10 Euro to TRINE for clean energy projects)

Cancellation policy - Compliance Seminars®  

Cancellation of registration:

Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.

Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.