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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 industry:
This course reviews and interprets the current FDA compliance requirements for the production and control of sterile pharmaceuticals, and discusses the practical techniques for conducting an effective and efficient audit.
The topics selected for this course include the GMP compliance requirements for various aseptic processing controls; a compliance and technical review of aseptic filtration, lyophilization technology, and HVAC and WFI systems; and the current compliance issues for isolator technology, media fill, and microbiological environmental monitoring.
• Sterile Product Processing Controls
• Sterilization Parameters: Practical Application of
F, D and Z Values, Including Class Exercises
• Designing, Validating and Revalidating Sterilization Cycles
• Environmental Requirements for Clean Rooms
• Microbiological Monitoring for Sterile Operations
• Disinfection and Sanitization (D&S) Programs
• Aseptic Filtration
• Media Fill: Validation Requirements and Recommendation
• Water-for-Injection Systems
• Lyophilization Technology
• Isolators
This course will provide the attendees with the GMP compliance and technical knowledge to evaluate the controls for sterile pharmaceuticals and ensure compliance with FDA requirements.
This course is intended for Compliance Auditors, Quality Assurance and Production professionals. Regulatory Affairs and Research and Development professionals involved in the support for sterile pharmaceuticals should also attend.
Feedback from participants:(4.3 of 5) "Super course! Thanks!" "Mr John Lee is a very good lecturer." "I like the course a lot! Maybe a little bit more interaction by the audience would be nice." |
Course No:5303 |
Instructor: |
Next course:March 19-21, 2012 |
Course venue: |
Agenda:Day 1: 8.30-16.30 (Registration 08.00-08.30) |
Price:€ 2.295 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
(4.3 of 5)