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The GMP board game that tests and improves your GMP compliance, knowledge, attitude and awareness!
Collection of GMP's for pharmaceutical production
The GMP Handbook for pharmaceuticals
Quality Systems Handbook for MedDev
E-books: US and EU regulations
GMP translations (FR, IT, SE, DK)
Search tool and document library. Find your way in regulations, guides and other reference documents.
Pharmaceutical and biopharmaceutical industry
This course is aimed at managers, supervisors and technical staff working engineering departments and support functions in the pharmaceutical industry and external suppliers. It will assist them in understanding and applying relevant Good Pharmaceutical Practice (GxP) principles to practical workplace situations.
The difference between GEP and GxP will be discussed with the delegates, who will go on to establish the implications and potential risks to product safety which can result from engineering activities and the steps that must be taken to ensure regulatory compliance.
A hands-on, practical approach is taken with the course and the delegates learn through accessing the various rules, regulations and guidelines as they work through a series of Key Subject Areas:
Introduction to GMP/cGMP in pharmaceutical/biopharm Industries
Current regulatory thinking – risk management
QA/QC issues associated with engineering activities
Documentation
Contamination control
Validation
Self Inspection (Internal audits)
The objectives of the course are that delegates will:
Understand the regulatory requirements and constraints facing engineering groups in the pharmaceutical industry
Become familiar with the relevant sections and clauses of the EU Guide, FDA CFRs, FDA Guidance for Industry series and various industry guidance documents and web sites – in particular, the aim is that the delegates will know where to go to source information relating to various issues and challenges.
Develop their operation's process and identify the controls necessary to ensure compliance with GMP/GxP regulations and guidelines and the application of GEP.
Engineering managers, supervisors and technical staff - both front-line and support functions - will benefit from this course.
Feedback from participants:(4.0 of 5) |
Course No:5224 |
Instructors: |
Next course:NMay 23-24, 2012, Copenhagen, Denmark |
Course venue: |
Agenda:Day 1: 10.30-17.00 (Registration 10.00-10.30) |
Price:€ 1295 incl. course material, lunches and refreshments |
Discounts:We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements. |
Cancellation policy:Registration is binding and when you have received our confirmation the following conditions are know 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 21 calendar days before course start are subjected to a service charge of 200 € (Euro). Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full. Courses may be cancelled by the organizer if bookings fail to reach minimum numbers, and in such circumstances course fees will be refunded, or granted to attend another course for the same value. We are not responsible or liable to any costs in conjunction with a cancelled course. Under normal conditions a cancellation decision is taken +6 weeks prior the course start. |
Lundén/Ellow ab and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Tel: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com
(4.0 of 5)