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Data Integrity FDA/EU Requirements and Implementation 2017

Start Date:
Wednesday, 27 September, 2017
End Date:
Thursday, 28 September, 2017 6:00pm
Oncology, Dermatology, Nephrology, Neurology, Gastroenterology, Immunology, Psychiatry, Cardiology

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 healthLearn why there are so many data integrity issuesLearn about the FDA/EU/PICS/MHRA/WHO requirements for data integrityUnderstand how to define and archive raw data from hybrid systems: electronic vs. paperBe able to specify and validate Part 11 compliant software functionalityLearn how to ensure and document integrity of raw data and other records according to Part 11 and Annex 11Understand FDA's New and ongoing Part 11 inspection and enforcement practicesLearn how to develop and implement corrective and preventive action plans in response to inspection reportsLearn how to avoid and/or respond to FDA inspectional observations and warning lettersLearn how to prevent and detect data integrity issues Who Will Benefit: QA managers and personnelLaboratory managers and supervisorsProduction managers and supervisorsAnalystsIT/IS managers and system administratorsSoftware developersRegulatory affairsTraining departmentsDocumentation departmentsConsultants Agenda: Day 1 Schedule Lectures and Workshop Exercises Lecture 1:Definitions, requirements and approaches for data integrityDefinition of data integrity: ALCOA+The importance of data integrity for public healthMain reasons for non-complianceRegulations and guidelinesFDA's inspection and enforcement strategy of Part 11Lessons from recent FDA Warning Letters and how to avoid themLecture 2:Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11Objective, scope, current situation and future of Part11Requirements for electronic recordsRequirements for electronic and digital signaturesAdditional requirements from the PICS/EU Annex 11,Developing a gap analysisUpgrading existing or purchasing new systems:Six steps for implementation of Part11/Annex 11Lecture 3:Strategies to detect and avoid integrity issuesRecruit, train and retain employees who will be responsible for ensuring data integrityPreventing data integrity issues: Going through details of ALCOA+Possible causes for data integrity breachesUnderstand system vulnerabilities, motivation and likelihood operators might compromise dataUnderstand the company's quality cultureUnderstand high risks in the data lifecycleLearning from internal audits and FDA inspectionsLecture 4:The Quality System as Prerequisite for Data IntegrityContributing factors to poor qualityConsequences of poor quality systemsRecommendations from the FDADeveloping a Quality CultureICH Q10 - The quality system for pharma industryImplementing key requirements: e.g., CAPA system, failure investigations, training, auditsAssessment of data integrity risksSteps for on-going improvement Day 2 Schedule Lectures and Workshop ExercisesLecture 5:Cost effective Validation of software and computer systemsSelecting the right validation lifecycle modelGoing through examples of a complete computer system validation from beginning to endHow risk assessments can help to determine the type and extent of validationDefining user requirements based on riskVendor assessment and supplier agreementsTesting and documenting installationGoing through examples for OQ and PQ testingMaintaining the validated state Lecture 6:Definition and Handling of Raw DataDefinition of Raw DataExamples of raw dataRaw data for paper based and electronic systemsCriteria for electronic raw data with paper print-outsRaw data management along the data lifecycleChanging of raw dataArchiving of raw data from electronic and hybrid systemsGoing through examplesLecture 7:Good documentation practices to ensure data integrityRequirements for documentation ( ALCOA+)Documents that must be readily availableExamples for good and bad documentationGood practices for paper and electronic dataHow to avoid common documentation mistakesThe importance of global documentationExamplesLecture 8:Data Integrity Auditing: Internal and FDA inspectionsGoing through a typical FDA inspection as a model for internal auditFDA's new approaches to data integrity inspectionsTypical audit questionsIdentifying systems that must be audited based on riskTypical audit findingsThe importance of the exit meetingWriting a corrective and preventive action plan to fix data integrity audit findings SpeakerDr.

Ludwig HuberChief Advisor - Global FDA compliance, Labcompliance Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferencesServed as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP special interest group on Laboratory Systems.Presenter of the Year of the Institute for Validation and TechnologyDirector and chief editor of, the global on-line resource for validation and compliance issues for laboratories.Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems" Location: Zurich, Switzerland Date: September 27th & 28th, 2017 and Time: 9:00 AM to 6:00 PMVenue: 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: $1,895.00Register 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" seminarAt 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- Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}


Hilton Zurich Airport Hohenbuhlstrasse 10,
8152 Opfikon-Glattbrugg,
Switzerland. +41 44 828 50 50

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
Event Manager

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