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Event NameGlobal CompliancePanel 2016 GMP for Quality Control and Contract Laboratories
Event Date(s) Tuesday, November 29, 2016  to Wednesday, November 30, 2016
Event Location Hilton Zurich Airport
Cost$1,895 - $2,295
DescriptionQuality control and related contract laboratories are considered high risk because after testing and approval drug products and APIs are released to the market without further check. That's the reason why FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation.

This 2-day interactive seminar provides the regulatory background and guides attendees through all critical areas of GMP compliance. The course not only helps attendees to understand the requirements but also provides templates and examples to develop inspection ready documentation. Practical examples and interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course

Why should you attend:

• Learn about the regulatory background and GMP requirements for quality control and contract laboratories
• Understand details of GMP requirements along the entire sample and data workflow
• Understand and be able to explain your company's quality plan or laboratory compliance master plan
• Understand the difference between GMP and non-GMP Laboratories
• Learn how to develop inspection ready documentation
• Be able to train others in your organization on GMP, 21 CFR Part 11 and Annex 11 requirements
• Learn how to avoid and/or respond to FDA inspectional observations and warning letters

Who will benefit:

• Analysts and Lab Managers
• QA Managers and Personnel
• Validation Specialists
• Regulatory Affairs
• IT Professionals
• Human Resources (HR) Managers and Staff
• Training Departments
• Documentation Department
• Consultants, Teachers


• Pharmaceutical manufacaturers
• API manufacturers
• Quality control laboratories
• Contract laboratories
• Contract manufacturers
• Suppliers and service providers of instruments and computer systems
Host CompanyN/A
Contact Information Phone: +1-800-447-9407
Fax:   302-288-6884 
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