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Course "Data Integrity: FDA/EU Requirements and Implementation" has been pre-approved by
RAPSas eligible for up to12credits towards a participant's RAC recertification upon full completion.Overview:
There is no doubt that data integrity is the current and future inspection focus of all regulatory health care agencies. More than 50% inspection reports such as 483's and Warning Letters quote data integrity as deviations from GxP regulations.
This new two-day course provides the regulatory background and guides attendees through the complete record lifecycle from data entry or acquisition through evaluation, reporting, archiving and retrieval. It also helps to fully understand not only the text but also the meaning of related regulations such as FDA's Part 11 and the EU/PICS Annex 11.
This two-day course not only ensures a full understanding of the regulations and guidelines for raw data and other records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.
Learning Objectives:
Who Will Benefit:
Agenda:
Day 1 Schedule
Lectures and Workshop Exercises
Lecture 1:
Definitions, requirements and approaches for data integrity
Lecture 2:
Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11
Lecture 3:
Strategies to detect and avoid integrity issues
Lecture 4:
The Quality System as Prerequisite for Data Integrity
Day 2 Schedule
Lectures and Workshop Exercises
Lecture 5:
Cost effective Validation of software and computer systems
Lecture 6:
Definition and Handling of Raw Data
Lecture 7:
Good documentation practices to ensure data integrity
Lecture 8:
Data Integrity Auditing: Internal and FDA inspections
Speaker
Dr. Ludwig Huber
Chief Advisor - Global FDA compliance, Labcompliance
Location: Zurich, Switzerland Date: September 27th & 28th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Hilton Zurich AirportHohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50
Price:
Register now and save $200. (Early Bird)
Price: $1,695.00 (Seminar Fee for One Delegate)
Until August 10, Early Bird Price: $1,695.00 From August 11 to September 25, Regular Price: $1,895.00
Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*
Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship
Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com
Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901060SEMINAR?ticketforevent-September-2017-SEO
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GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.
GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.