An NSF International Company M7 - Working with Regulatory Agencies - Regulatory Agency Enforcement & Remediation for Medical Devices (QP)
PrintPart of Medical Devices QP Training Module 7
£1740.00 exl VAT
About this course
A two day course aimed towards medical device manufacturers that are actually or potentially in regulatory enforcement proceedings. The course takes you through how regulatory enforcement action is taken, from the simple generation of a quality system or technical file non-conformity to a whole scale multi competent authority lead safeguarding action. This two day course takes you through the necessary skills, report writing, coordination, project planning and legal interactions necessary to effectively address regulatory enforcement and also outlines in no uncertain terms the effects and likely impacts that can be expected when regulatory enforcement ensues. The course provides you with specific guidance as to how to work with and respond to regulatory agencies including notified bodies, Competent Authorities and European Commission agencies in the light of regulatory action.
Who Should Attend
The course is aimed at personnel within the organization involved specifically with scientific and/or regulatory affairs strategic planning and regulatory enforcement. In a world where regulatory scrutiny has increased several-fold it is crucial that professionals are capable of communicating effectively with their regulatory agency at pre-clinical, pre- submission, submission and regulatory enforcement phases. The course also provides excellent guidance upon responding to regulatory agencies during times of business critical enforcement.
