Ensuring Integrity and Security of Laboratory Data

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.

Areas Covered in the Seminar:

• 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.

Who Will Benefit:

• All companies generating laboratory records in regulated environments
• Pharmaceutical and Device Manufacturers
• API Manufacturers
• Contract Laboratory Organizations providing services for GxP compliance
• Documentation professionals
• QA/QC managers and personnel
• Analysts and lab managers
• Validation specialists