Excel Spreádsheet Compliant with Part 11 and Computer System Validation: Dos and Don’ts
Live Webinar | David Lim | Oct 05, 2017, 01: 00 pm EST | 60 minutes
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Description
In FDA-regulated industry, it is imperative that firms demonstrate ádequate implementation of Excel Spreádsheet 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 àdequately develop and implement the requirements for Excel spreádsheets used in GMP environment under Part 11 and computer system validation. Ádequate implementation of Excel spreádsheets for Part 11 compliance will ensure quality and integrity of GxP data and avoid FDA enforcement actions leáding 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 àdequate 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 chéck your current practices and/or also to ensure your compliance with part 11 requirements and computer system validation for Excel spreàdsheets 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
Mail us: cs@onlineaudiotraining.com | Cäll us: +1-800-935-3714
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