 |  |
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 course reviews the GMP compliance requirements for validation and qualification, and the latest FDA interpretations of these GMP requirements and issues. This course also reviews current compliance issues, such as revalidation and requalification, qualification of existing equipment, and provisions for validation/qualification matrixing and bracketing. The topics for review and discussion include process validation, installation and operation qualifications, validation documentation, cleaning validation and computer validation.
This course is suitable for professionals with a basic or advanced knowledge of GMP/FDA requirements and compliance issues for validation and qualification. The course will benefit Quality professionals with responsibility for validation compliance and auditing; and Validation, Engineering and Production professionals with responsibilities for the execution of the validation/qualification, and the preparation of related records.
• GMP Review and Interpretations for Validation and Qualification
- Current GMP and FDA requirements
- Performance qualification versus process validation
- Interpretation and application of commissioning, design qualification,
FAT and SAT
- Conditions and limitations for retrospective and concurrent validations
- Objective and preparation of master validation plans and related records
- Worst-case, and bracketing and matrixing
- Current compliance issues
• Preparing the Validation/Qualification Protocols
• Compliance Requirements for Installation Qualification
• Compliance Requirements for Operation Qualification
• Compliance Requirements for Process Validation
• Compliance Requirements for Computer Validation
• Compliance Requirements for Cleaning Validation
• Preparing the Validation/Qualification Report
The objectives of this course are to provide the attendees with an updated review of the latest GMP requirements and FDA interpretations for validation and qualification, and practical recommendations for the most effective and efficient methods to achieve a satisfactory level of compliance.
Feedback from participants:(4.5 of 5) "Very good course! Good answers on questions" "Many good examples from real life. (e.g.”483s”, warning letters) and many personal stories"! |
Course No:5206 |
Instructor: |
Next course:November 17-18, 2011 Copenhagen, Denmark |
Course venue: |
Agenda:Day 1: 8.30-16.30 |
Price:€ 1.895 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
(4.5 of 5)