Description

In FDA-regulated industry, it is imperative that firms demonstrate adequate implementation of Excel Spreadsheet validations compliant with 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 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….”

Why Should you attend?

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

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