In FDA-regulated industry, it is imperative that firms demonstrate 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 to understand the compliance requirements better 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 excellent opportunities to check your current practices and 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:-
Who will Benefit:-