2015 - Webinar Ensuring Data Integrity for FDA/EU Compliance

Description :
FDA has found and reported about multiple cases where companies manipulated electronic records. Since then FDA inspectors have focused inspections on security, availability, accuracy and integrity of 'complete' records. FDA has trained inspectors to identify data falsification and recommended the same to industry QA departments and auditors. Just in the last three years FDA issued over 30 warning letters and 483 form inspectional observations related to electronic records. The industry is unsure how to comply with FDA inspection requirements. Because of missing clear guidance from the FDA the industry has lots of questions. Using recent warning letters as examples, this seminar will demonstrate how current data integrity requirements will be identified, implemented and documented.
For easy implementation, attendees will receive
SOP: Integrity and Security of Electronic Records
SOP: Review of Electronic Audit Trail
Checklist: Security and Integrity of Electronic Data for Part11/Annex 11 Compliance
Areas Covered in the Session :
Eight key FDA/EU requirements for integrity and security of electronic records
How FDA inspectors check integrity of data
Most frequent data integrity issues: going through recent 483's, EIRs and warning letters
The importance of limited access to 'individual users' rather than to groups
FDA compliant definition, acquisition, maintenance and archiving of raw data
Critical integrity and security issues during the entire life of records
Examples how to ensure and document data integrity
Documenting changes of regulated data: paper, hybrid systems, electronic
The importance of electronic audit trail to document data integrity
Review of electronic audit trail: who, what, when and how
Ensuring timely availability of data through validated back-up and archiving
Required skills and responsibilities of internal and 3rd party consultants?
Going through representative case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions
Who Will Benefit:
Everybody using computers in FDA regulated environments
IT managers and staff
Manufacturers of drug substances (APIs)
Medical Device Manufacturers
Analytical Contract laboratories
Clinical contract laboratoriers
QA managers and personnel
Quality control directors or delegates
Internal auditors
Regulatory affairs
Training departments
Consultants
Validation specialists
Price tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support-AT-compliancetrainings.com
For more information about this event please visit
https://compliancetrainings.com/SiteEngine/Product...