Meetings/Workshops on Healthcare Systems and Hospital Management in Denmark
Select a location
Data Integrity: FDA/EU Requirements and Implementation
18 Jun 2020 - 19 Jun 2020 • Copenhagen, Denmark, Denmark
Data integrity has been a focus for pharmaceutical regulatory inspections for a number of years and look set to remain of concern to regulators and manufacturers for many years to come. Many inspection reports from regulatory agencies around the world cite data integrity as a cause of observations and enforcement action, and actions taken by regulators to restrict the commercial activities of manufacturers on the grounds of data integrity violations have obvious serious consequences for the company concerned. This 2-day course explains the background to the data integrity regulations and sets out the expectations of pharmaceutical regulators. All the current data integrity guidances emphasise a risk-based approach to compliance, and the course explains how to evaluate and control data integrity risks. A key resource in relation to electronic records is GAMP 5, which deals with controlling risk and managing computerised systems over their life cycle. The practices recommended by GAMP 5 will be dealt with in detail, and practical advice on the appropriate use of Excel spreadsheets given. Data integrity should not be thought of as an exclusively analytical problem, and examples of data integrity violations in production will highlight the risks during manufacturing.
Phone: ; Email: email@example.com
data integrity workshop, gxp regulations, fda part 11, eu/pics annex 11, fda part 11 inspection, data integrity issues, fda warning letters, fda 2a cfr part 11, good documentation practices, ich q10, workshop by Br. Mark Powell
Conference-Service.com offers, as part of its business activities, a directory of upcoming scientific and technical meetings. The calendar is published for the convenience of conference participants and we strive to support conference organisers who need to publish their upcoming events.
Although great care is being taken to ensure the correctness of all entries, we cannot accept any liability that may arise from the presence, absence or incorrectness of any particular information on this website. Always check with the meeting organiser before making arrangements to participate in an event!
Last updated: 28 April 2020