 |  |
RSS feed (English)
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 industry
This seminar is designed for professionals already familiar with GMP and quality concepts and covers a walk-through of ICH Q8/Q9/Q10 in relation to GMP compliance.
Each of the Quality System elements:
- Management Controls
- Design Controls / Development
- CAPA (Corrective and Preventive Actions)
- Risk Management
will be covered and each session will have following structure:
• Introduction about the principles in the particular QS element
• Issues from Q8/Q9/Q10 of interest from compliance and
auditing perspective
• Specific examples with real-life situations covered
As a reference to each session, the participants will be provided a matrix with references to various GMP and ISO paragraphs. The seminar includes workshops which will enable the participants to discuss, interact, and share experiences with professionals from the industry.
After the seminar each participant will be able to complement previous GMP-knowledge with the three ICH documents as an additional tool. This seminar will add knowledge about how the various QS-elements, as described in the ICH-guides, can be applied on various compliance situations.
Professionals in the dosage form pharmaceutical manufacturing industry knowledgeable in GMP’s. The seminar is interesting for quality and manufacturing management who needs to have a deeper understanding of the the influence of implementation of the ICH Q8/Q9/Q10 guidelines. Compliance auditors may also gain useful information for quality system auditing.
Course No:5106 |
Faculty: |
Next course:No sheduled course date. Contact us for more information. |
Course venue:- |
Agenda:9.00-17.00 Registration 08.30-09.00 |
Price:€ 595 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
