Archiving GLP Records: How Archiving Makes or Breaks the Audit

Why Should You Attend:

GLP requirements for archiving provide specific requirements FDA has for preclinical lab records and documentation. This webinar will review practical application of how the regulations should be implemented to obtain optimal compliance.

Most laboratory data today are recorded and stored electronically. This webinar will review the acceptable methods for archiving electronic records versus the requirements for manual records archiving.

FDA has cited companies for common areas of non-compliance when it comes to GLP records. These mistakes can be avoided using the proactive steps that will be discussed during this webinar.

Maintaining an audit ready records archival repository can facilitate a smooth audit process and help to alleviate the stress of a regulatory inspection or other audit. During this webinar the attendee will become armed with practical steps to proactively ensure a smooth audit process regarding GLP Record Archival.

Areas Covered in the Webinar:

• Review of GLP Records Archiving regulations
• The role and responsibilities of the archive and archivist.
• Options for archiving electronic and manual records
• Organizational structure of archives
• Proactive steps to avoid common archiving pit falls
• FDA expectations during an audit
• Archiving practices that facilitate a smooth audit process by regulatory agencies
• Inspection/Audit readiness actions

Who Will Benefit:

• GLP and GCP Study Directors
• Lab Directors
• QA professionals
• Documentation Control Managers
• Records Management Professionals
• Company Sponsor managers
• Company Sponsor archivists
• Commercial archivists

Marschall Robyn White
President and Principle Consultant, Ascension GxP Solutions, LLC

M. Robyn White, MBA, CQA is the President and Principle Consultant at Ascension GxP Solutions, LLC and also works as an independent consultant for DPS Engineering. She has more than 25 years’ experience in design and implementation of Quality Management Systems, Quality Assurance programs and Regulatory Compliance programs in Pharma, Medical Device and Biologics Industry. Robyn works with various start-up to well established companies to build or re-vamp their Quality Assurance programs and ensure compliance with GMP, GCP and GLP regulations as well as ISO requirements. Her strength is in technical writing, documentation, procedure manuals, and SOPs and GXP Auditing and inspection readiness for FDA, EU, MHRA and other international agency regulatory compliance. Robyn has successfully hosted many FDA inspections and international regulatory inspections resulting in no 483 observations being issued and has helped clients respond to citations with successful remediation including consent decree management.

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