Collection of GMP's for pharmaceutical production
The GMP Handbook for pharmaceuticals
Quality Systems Handbook for MedDev
GMP translations (FR, IT, SE, DK)
Search tool and document library. Find you way in regulations, guides and other reference documents.
Anna Lundén is training manager and part owner in Lundén/Ellow ab, a training and consultancy firm specialising in compliance and quality systems training in Europe. Lundén/Ellow AB and EuroGMP® AB (a European subsidiary to L/E) supplies information and training in Europe with the speciality of comparing US and EU regulations and also deliver GMP and Quality Systems training in various languages to the health care industry.
She works in close contact with the industry with both training and consultancy and has developed various training modules for many different levels of employees, from top management to line operators. She has long experience of working with European companies dealing with FDA requirements and expectations. Prior to founding Lundén/Ellow in 1995, she worked for 13 years with the Nordic distributor to Pall Europe Ltd and gained extensive practical knowledge about technical process and product applications in the area of membrane filtration.
Ms. Lundén is regularly invited as a popular trainer at the QSR/ISO 13485 and regulatory trainings held by SIS, Swedish Standards Institute.
She is the author of "The GMP Handbook" and "Quality System Handbook for Medical Device" , has participated in the development of KEY2GMP®, a search tool for compliance information and has developed a unique training concept for interactive classroom training for operators, "The GMP Game".
» Grundkurs i GMP, Good Manufacturing Practices #4113
» Introduktion till kvalificering och validering #4114
» GMP-krav på datorsystem, Inkl 21CFR Part 11 #4211
» Fördjupningskurs i CGMP för läkemedelstillverkning #4212
» Validering och kvalificering med praktiska övningar #4301
» Medicintekniska produkter i EU och USA &
Kvalitetssystem för medicinteknik, QSR och ISO 13485 #4213
