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Data Integrity FDA/EU Requirements and Implementation 2017

Data Integrity FDA/EU Requirements and Implementation 2017

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Who should attend?

QA managers and personnel Laboratory managers and supervisors Production managers and supervisors Analysts IT/IS managers and system administrators Software developers Regulatory affairs Training departments Documentation departments Consultants

Details

Course "Data Integrity: FDA/EU Requirements and Implementation" has been pre-approved by RAPS as eligible for up to 12 credits 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:

 

Understand what data integrity is and why it is so important for public health
Learn why there are so many data integrity issues
Learn about the FDA/EU/PICS/MHRA/WHO requirements for data integrity
Understand how to define and archive raw data from hybrid systems: electronic vs. paper
Be able to specify and validate Part 11 compliant software functionality
Learn how to ensure and document integrity of raw data and other records according to Part 11 and Annex 11
Understand FDA's New and ongoing Part 11 inspection and enforcement practices
Learn how to develop and implement corrective and preventive action plans in response to inspection reports
Learn how to avoid and/or respond to FDA inspectional observations and warning letters
Learn how to prevent and detect data integrity issues

 

 

 

Location: Zurich, Switzerland Date:  September 27th & 28th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:   Hilton Zurich Airport   Hohenbuhlstrasse 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?pharmiweb-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

Prices

Price: $1,695.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)* Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)* Register now and save $200. (Early Bird)

Contact

Event Manager
john.robinson@globalcompliancepanel.com

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