Compliance Trainings, Canada
2015-05-20
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@compliancetrainings.com
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