Client Experience
QRC clients include pharmaceutical, bio-tech, nutraceutical, medical device, tobacco, and other ISO regulated organizations. These companies seek professional assistance possessing the knowledge, skills, and abilities capable of providing a sustainable and value - added solution to a specific need or issue that they are faced with in a dynamically changing world.
We think in terms of a “Client System” that places our client(s) at the center of our efforts in order to provide practical business, compliance, quality, scientific and/or technical solutions. It is the establishment of this client relationship and our ability to advise, guide, coach and mentor our clients at different levels that results in solving a problem or achieving a specific objective through the use of credible and competent knowledge, skills, and abilities.
The QRC “Client-Centered” approach is about:
· Starting with an assessment of where our clients really are, not just where they think they are
· Helping our clients to collect data and assist in the conversion of that data into meaningful management information
· Assisting our clients in the establishment of practical solutions and commitment to an action plan
· Helping our clients to implement solutions and arrange follow-up, if appropriate
· Ensuring that clients retain ownership of the solution and don’t become dependent on QRC
Summary of Experience
• Compliance and Quality Master Planning
• Consent Decree Program Management
• Continuous Improvement and Team-Building
• Corrective and Preventive Action Programs
• Data Architecture, Measurement and Analysis
• Education and Training Programs
• Enterprise – Wide Quality Assurance Programs
• FDA 483 and Warning Letter Remediation
• Integration of ISO and GMP Quality Systems
• Merger and Acquisition Due – Diligence
• Organization Cultural and Performance Assessments
• Process Characterization and Improvements
• Product Development Specific Quality Planning
• Project Management and Facilitation
• Quality Systems Architecture and Design
• Science – Based Risk Management Programs
• Validation Program Development and Realization
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| Case Studies: FDA Warning Letter Remediation |
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| Case Studies: Training & Knowledge Transfer |
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| Case Studies: Quality System / Best Practises |
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