Why Should You Attend:
The FDA has found and reported multiple cases where companies manipulated electronic laboratory records to bring out-of-specification results into specifications. Since then FDA inspectors have focused during GLP, GCP and GMP inspections on security, availability, accuracy and integrity of 'complete' laboratory records. The FDA has trained inspectors to identify data falsification and recommended the same to industry QA departments and auditors.
In the last three years alone, the 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.
This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.
Complimentary Hand-outs:
For easy implementation, attendees will receive
SOP: Integrity and Security of Electronic Laboratory Data
Checklist: Security and Integrity of Electronic Data
SOP: Electronic Audit Trail - Specification, Implementation, Validation
10 Case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions
Areas Covered in the Webinar:
Eight key FDA/EU requirements for integrity and security of laboratory data
How FDA inspectors check integrity and security of data
Most frequent security and 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 laboratory data: from data acquisition through evaluation to archiving
Examples how to ensure and document data integrity
Documenting changes of laboratory 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 through validated back-up and archiving
Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions
The FDA has found and reported multiple cases where companies manipulated electronic laboratory records to bring out-of-specification results into specifications. Since then FDA inspectors have focused during GLP, GCP and GMP inspections on security, availability, accuracy and integrity of 'complete' laboratory records. The FDA has trained inspectors to identify data falsification and recommended the same to industry QA departments and auditors.
In the last three years alone, the 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.
This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.
Complimentary Hand-outs:
For easy implementation, attendees will receive
SOP: Integrity and Security of Electronic Laboratory Data
Checklist: Security and Integrity of Electronic Data
SOP: Electronic Audit Trail - Specification, Implementation, Validation
10 Case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions
Areas Covered in the Webinar:
Eight key FDA/EU requirements for integrity and security of laboratory data
How FDA inspectors check integrity and security of data
Most frequent security and 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 laboratory data: from data acquisition through evaluation to archiving
Examples how to ensure and document data integrity
Documenting changes of laboratory 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 through validated back-up and archiving
Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions
Agenda
- Eight key FDA/EU requirements for integrity and security of laboratory data
- How FDA inspectors check integrity and security of data
- Most frequent security and 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 laboratory data: from data acquisition through evaluation to archiving
- Examples how to ensure and document data integrity
- Documenting changes of laboratory 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 through validated back-up and archiving
- Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions
