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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.
This course is arranged in association with:
(The Association for the Advancement of Medical Instrumentation)
Medical Device industry
This 2½ day program provides regulatory affairs experts, quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System regulation while offering information on how to implement an effective validation program. In 2006, FDA brought the course in-house to train Office of Compliance employees.
Upon completion of the course, participants will be able to apply the principles of process validation to their operations and know how to choose relevant statistical tools and techniques. Participants will also come away with an understanding of the final process validation guidance issued by the Global Harmonization Task Force in 2004.
This program provides intensive coverage of the elements of process validation. The highly interactive format includes a variety of situational analyses that provides you with the opportunity to apply new information to actual process validation scenarios. Industry "best practices" are presented to demonstrate examples for compliance strategies. In addition, participants will work through a series of case studies that illustrate the various aspects of a validation program.
The course consists of 2½ days of intensive coverage and practical application of the elements of process validation, including:
Day 1 |
• Introduction and Overview to Process Validation |
Day 2 |
• Process Operational Qualification (OQ) |
Day 3 |
• Process Monitoring, Control and Documentation |
Instruction is targeted to professionals directly involved in meeting FDA's Quality System requirements such as those in regulatory affairs, quality assurance, process development, or manufacturing. To maximize the peer learning opportunity, this course is recommended for those who already have a basic understanding of the Quality System regulation, including direct work experience.
Course No:5309 |
Instructor:- |
Next course:No sheduled course date. Please contact us for more information. |
Course venue:- |
Agenda:Day 1: 8.00-17.00 (Registration 07.30-08.00) |
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. 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 200 € + 100 €/course day (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. |
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
