QFI COLLEGE PROGRAMME OF COURSES
Principles and practice of remedial action: non-conformity, corrective and preventive actions
Description of the course
This one-day seminar is designed to examine the origin of action demanded by EN ISO 9000 and EN ISO 13485, concentrating on corrective and preventive action (CAPA), their relation to one another and to correction. Attendees will learn to differentiate action, analyse episodes of non-conformity and resulting action, devise solutions, and plan and manage efficiently.
Regulatory obligations arising from the General Product Safety Directive transposed into EU Member State regulation, Product Liability Directive, Directives on medical devices placed on the market in the EU, and obligations prescribed in EN ISO 13845 receive attention.
The course concentrates on elements applying to products placed on the market with the CE mark according to various European Directives on medical devices. Where appropriate, attention is devoted to US expectations.
The objective of the course is to introduce principles and practices of remedial action.
Who should attend
The course is designed for individuals with an understanding of quality management systems’ concepts, including GMP, an awareness of EN ISO 13485 and EN ISO 9000 series standards and the European regulatory domain who are involved in CE compliance, regulatory, quality and technical functions.
Documentation and certification
Full course documentation is provided, consisting of a 77-page manual, Microsoft® PowerPoint presentation and (where requested) examinations and exercises. Certificates of attendance, completion or achievement, etc are offered.
The course can be delivered on-site or in-house at the offices of Quality First International in London.
For bookings and registration, please contact:
t: +44 (0)208 221 2361