Quality Architech®
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.
Our clients depend on us to:
- Audit existing systems
- Create and implement new systems and processes to ensure compliance
- Train employees to ensure sustainability
- Build methods for system and process maintenance
Other expert services offered by Quality Architech® include:
Pre-Paid Quality Coaching
Sometimes, you don’t require an onsite consultation, but rather you just need answers to your quality and compliance challenges. In these instances, we offer Pre-Paid Quality; a telephone coaching and mentoring consultation support service.
This unique offering enables you to pre-purchase blocks of time, so that you can get answers to your questions quickly and efficiently.
For further information, please contact Christine at 678-480-5411.
Consulting Services
We also offer quality system and business process consulting (including startup, remediation, streamlining processes, regulatory compliance and more). Please call Christine for a proposal at 678-480-5411 or click here to fill out the contact form (feel free to add a comment or ask a question)
Areas of Expertise
Christine employs her vast experience and expertise to quality system development and remediation, including:
- Management controls (including audits, training, management review)
- Supplier quality
- Production & process controls – including process validation
- Document controls and management
- Change Control – production and design
- Preventative/corrective actions (CAPA)
- Complaint management
- 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
