Mindful Quality consultants are quality consultants. We focus on quality and patient safety first and foremost. Our experienced industry leaders can support your organization as needed. We have experienced Auditors, Investigators, Technical Writers, and Batch Reviewers who can lend a hand to your team as needed.
Interim Leaders & Mentors
Mindful Quality have experienced industry leaders who can keep your organization moving forward, lead and defend during inspections, mentor younger team members, and keep the organization focus on meeting the company goals and objectives.
Mindful Quality consultants draw from their industry and consulting experience to provide your leaders with practical advice, encouragement, and perspectives to help them strengthen their leadership capabilities.
Quality Management Systems (QMS) Development & Optimization
With experience designing, building, and managing QMS programs, our experts understand the complex regulatory elements and compliance systems required for your organization to succeed. We will help guide your team through the regulatory processes specific to your quality programs.
Our consultants will ensure your QMS achieves three objectives:
Regulatory requirements, right-sized processes for the phase and scope of the organization and continuous improvement.
Quality Investigations & CAPA Support
Mindful Quality consultants understand that a risk-based response is critical for all observed manufacturing, testing, and distribution discrepancies, or product complaints. Our diverse and experienced SMEs will integrate with yours to help investigate and determine the root cause. Based on the root cause, we will help you implement specific and effective corrective and preventative action (CAPA) to remediate and prevent the issue's reoccurrence and consequently facilitate continuous improvement.