Description

In FDA-regulated industry, it is imperative that firms demonstrate an adequate implementation of Excel Spreadsheet validations compliant with FDA expectations/requirements, 21 CFR Part 11 (Part 11) applicable to manufacturers for drugs, biologics/biosimilars and medical devices including IVDs. 

This conference will help firms better understand compliance requirements to adequately develop and implement the requirements for Excel spreadsheets used in GMP environment under Part 11 and computer system validation.  Adequate implementation of Excel spreadsheets for Part 11 compliance will ensure the quality and integrity of GxP data and avoid FDA enforcement actions leading to 483s and warning letters.

FDA frequently states “failure to maintain complete data; failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data; “failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system….”

This conference will provide great opportunities to check your current practices and/or also to ensure your compliance for part 11 requirements and computer system validation for Excel spreadsheets of GxP data.

Areas To Be Covered in this Seminar:-

• Applicable Statute(s) and Regulations
• Definitions
• GMP Requirements for Software
• Requirements for Excel Spreadsheets under 21 CFR Part 11
• Excel Spreadsheets for GxP Data
• FDA Enforcement Actions on the Excel Spreadsheets
• How to Avoid FDA 483s and Warning Letters
• Excel Spreadsheet Validation
• Computer System Validations
• Excel Data Validations
• Requirements for Excel Audit Trails
• Excel Validation Documentation Requirements
• PASS-IT Recommendations: Best Practices

Who will benefit:-

• CEOs
• VPs
• Compliance Officers
• Attorneys
• Regulatory Affairs
• Clinical Affairs
• Quality Assurance
• R&D
• Consultants
• Contractors/Subcontractors
• Anyone Interested in the FDA Drug Review and Approval Processes