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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.
• Regulatory Documents
• Definitions
• Compliance Philosophy
• Product Development
• Types of Validation
• Process Validation Program Documentation
- Process Validation Master Plan
- Conformance Lots
- Development Report(s)
- Step Reports for each Unit Operation
- Process Change History
- Formulation Development
- Analytical Methods History
- Process Validation Support Studies
• Process Validation and Product Approval
• Genetic Stability
• API & In-Process Impurity Profile
- DNA and Host-Cell Protein Removal
- Clearance of Process Additives
• Viral Clearance/Inactivation
• Process Pool Hold Time Studies
• Buffer Hold Studies
• Chromatography Cleaning, Storage & Reuse Studies
• Membrane Cleaning, Storage & Reuse Studies
• Final Filter Validation
• Final Bulk Container Validation
• Material Evaluation
Case Study: Pool Hold Studies
• Quality by Design
• Capturing Data
- Databases
- Initial Evaluations
• Determining Critical Parameters
• Use of Risk Assessments
• Setting Ranges
• Process Characterization
• Design Space
Case Study: Evaluating Parameters for Purification
Class Exercise: Evaluating Parameters for Fermentation
• Introduction
• Considerations for Process Development
- Compliance in Process Development Labs
- Process Validation Documents
- Protocols
- Reports
- Raw Material Issues
- Scale-up Issues
• Considerations for Analytical Laboratories
- General Considerations
- Testing to Support Process Development
- Testing to Support Clinical Manufacturing
- Assay Qualification/Validation
• Tolerances and Uncertainties
• Technology Transfer
• Quality Assurance Involvement
- General
- Process Development
- Testing During Development
Course No:5213 |
Instructor: |
Next course:October/November 2011, Copenhagen. Date will be posted in June. |
Course venue:- |
Agenda:Day 1: 08.30-17.00 (Registration 08.00-08.30) |
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
