As the Quality Architech®, Christine’s expertise provides direction and guidance that touches all aspects of your organization — from sales, marketing and customer service to distribution, logistics and quality and regulatory challenges. Through her vast expertise in working with clients in a variety of regulatory environments, Christine has found that the key is to focus on integrating processes that ensure an effective, resilient and sustainable Quality System. Christine employs a process-based approach to auditing, educating staff and creating flexible systems that can rapidly adapt to changing regulations and other external factors.
Choose an item below to learn more about the Quality Architech approach:
- Areas of Expertise
- Commitment to quality
- Creating a sustainable quality system
- Process-based auditing approach
- Assessing your quality system
- Setting the course for successful FDA inspections
Areas of Expertise
Christine employs her vast experience and expertise to quality system development and remediation, including:
Management controls (including audits, training, management review)
Production & process controls – including process validation
Document controls and management
Change Control – production and design
Preventative/corrective actions (CAPA)
Design controls – including risk management
Areas of specialization include:
R&D or general manufacturing arena for the medical device, IVD, and biotech/pharmaceutical environment
Extensive experience with ISO 9001, ISO 13485, 21 CFR 820, 600’s, 200’s; planning and hosting FDA inspections, ISO assessments
Customer and supplier audits
Commitment to Quality – Read Our Blog Here
When top management is committed to building a culture of quality, they consistently see the best results. This Quality Culture includes establishing best business practices by:
Defining key quality objectives and priorities
Educating and developing personnel
Supporting the auditing program
Implementing corrective and preventive actions in a timely manner
Monitoring results and providing the necessary resources to exceed FDA expectations
Creating a Sustainable Quality System
Focusing on integrated processes is critical to creating a sustainable quality system. An effective quality system = good integrated business process.
Companies who adopt a “silo” approach (that is, independent activity versus understanding the interrelationships between the activities) can have a negative impact on quality operations, and FDA inspections usually yield costly remediation efforts.
The Quality Architech approach is to convert silos into an integrated process, which ensures an effective, resilient, quality system.
Process-Based Auditing Approach – Read Our Blog Here
Internal auditing is a cornerstone of the Quality Management System and a vital tool to identify weaknesses and improve the overall effectiveness of our client’s operations. We use a process-based approach to auditing, rather than the “check the box” compliance approach. Essentially, we pull the thread throughout all operations touch points to assure compliance and effectiveness.
Assessing Your Quality System
Our back-to-basics approach employs sound, statistically based assessment metrics and tools to measure the effectiveness of your current quality system. Our core consulting role(s) include implementing remediation tools, personnel education and a high-level assessment and implementation approach.
Setting the Course for Successful FDA Inspections – Read Our Blog Here
During an FDA inspection, there is a big difference between being proactive versus being reactive. Establishing the right tools and processes allows you to anticipate the FDA investigator’s questions and requests; thus being more in control during an FDA inspection. We will coach you and your team to take appropriate corrective actions to address root cause compliance deficiencies.