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Inspection Readiness Assessment, Training, and Mock Inspections

The Avoca Group’s Consulting Services for Inspection Readiness provide full management through point-of-need support for inspections.

We aim to help sponsors and CROs develop a culture and mindset that are committed to quality through proactive risk management, ensuring an inspection readiness state throughout the entire clinical program.

 

View Avoca’s Inspection Readiness Webinar Recordings and Slides:

July 25, 2018: Risk-Based Inspection Preparation
September 25, 2017: Inspection Readiness Challenge
July 6, 2017: QMS and Inspection Readiness

 

Leverage Our Expertise

This service is based on our 20+ years of experience with risk mitigation, quality improvement, and commitment to efficiency in clinical trial execution. Our inspection preparedness model offers a comprehensive system that provides confidence for our clients.

 

We develop strategies, plans, and tools to navigate the diverse, changing inspection environment.

  • Leveraging our knowledge and information from daily inspection experiences
  • Utilizing the Avoca Quality Consortium® (AQC) Knowledge Center repository of global regulatory agency approaches to inspections and other industry experiences
  • Proactively aligning all Avoca processes and materials with new regulatory guidelines (e.g., ICH E6 (R2))

 

Clients benefit from a full team of dedicated experts—subject matter experts (SMEs) are paired to each project based on their expertise and ability to assess the areas of need.

  • Support for inspection readiness
  • Quality and compliance consulting/remediation support
  • Dedicated, embedded inspection lead to manage and report on inspection preparation activities

 

 

Trust Our Proven Process

Our agile inspection preparation process is based on industry-leading practices and tools for inspection readiness and proactive, ongoing inspection preparedness developed in collaboration with the 90+ AQC Member companies.

 

 

Be Inspection Ready

 

With The Avoca Group’s Consulting Services for Inspection Readiness, you can:

  • Discover trial-related issues with sufficient time to effectively manage the inspection risk.
  • Provide your staff with the experience and tools they need for inspection preparedness and situational competency to handle inspectors and auditors.
  • Gain insight into the inspection focus of health authorities.
  • Organize and collate trial-related documentation ensuring documentation is as organized and whole as possible in advance of a true inspection/audit.
  • Avoid delayed product launches and internal remediation costs resulting from inspection findings.
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Leverage Our Expertise. Trust Our Proven Process. Be Inspection Ready.

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Contact us to discuss your Inspection Preparedness needs:

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AVOCA QUALITY CONSORTIUM is a registered trademark of The Avoca Group. Copyright © 2018. All rights reserved.