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Quality Culture Program

QUALITY CULTURE

Quality Culture Improvement

What does it mean to have a “strong quality culture”?

What does it do for the bottom line of the organization?

What does the FDA say about inspections and quality culture?

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The FDA is challenging the way pharmaceutical and medical device companies are doing business. The FDA has raised the bar and made it clear; FDA regulatory compliance is just the starting point when it comes to operational excellence, commitment to quality and quality culture improvement. The FDA is going to ask about your organization’s commitment to quality. How will you demonstrate this commitment to quality culture?

Through a collaboration between Xavier Health, Price Waterhouse Coopers, SchellingPoint, and over twenty seasoned industry leaders, there is now a proven way to quantitatively measure an organization’s commitment to quality, their quality culture and steps being taken to improve quality culture.

What does the Quality Culture Improvement Program do?

  1. Highlights and prioritizes deficiencies in the quality system.

  2. Identifies functional misalignment across the organization.

  3. Provides direct quantitative measurement of quality culture.

  4. Creates a detailed Action Road Map that leads to a mitigation plan specific to improving your organization's quality culture.

The process begins with an interview (15-20 minutes), across all sectors of the organization. The higher the participation, the more accurate the Action Road map will be.

 

Request a consultation to find out more about the 7-step process that quantitatively demonstrates Quality Culture improvement.

Experience & Capabilities

  • FDA Compliance Consulting

  • Project Management

  • FDA 483 / Warning Letter

  • Consent Decrees

  • Systems Monitoring

  • GXP Training

  • Product Submissions

  • Due Diligence

  • Product Reviews

  • Registration & Listing

  • Audits

  • Gap Analysis

  • Regulatory Strategies

  • Inspection Preparation

  • GMP Services

  • GCP Services

  • FDA Submissions

  • Clinical Development

  • Nonclinical Development
  • Risk Based Assessment

  • Combination Products

  • Staff Augmentation

  • Electronic Publishing

  • Program Design

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