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- Moving towards quality systems
» Dr. Per Hyldebrink Damgaard, Novo Nordisk A/S
» Anna Lundén, Lundén/Ellow ab
Next course:
May 4, 2009, Copenhagen, Denmark
Course Venue:
» IDA Mødecenter, Copenhagen
Agenda:
9.00-17.00 Registration 08.30-09.00
Price:
€ 595 including seminar material, lunch, 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. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 150 € (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.
Industry field:
Pharmaceutical industry
Course description:
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.
Learning objectives:
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.
Who should attend:
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.
Lundén/Ellow ab and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Phone: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com