Chimera TQM
Total Quality Management
Accelerate your learning
and your career
Are you struggling with training and don’t know quite where to start?
Or do you know exactly what’s wrong and lack the resources
to get you past the bottleneck?
Let us guide you with a variety of solutions to meet your specific need!
With over 25 year of expertise in cellular therapy, including standard of care collection and processing, as well as a variety of novel cellular therapies, we have seen it all. We can help you gain skills and add to your quality repertoire. We also have experience in setting up new labs and helping established labs with process improvement.
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Areas of Expertise
General Cellular Therapy
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Process Improvement
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Quality Management Plan
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Accreditation & Regulatory Compliance for Cellular Therapy
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Auditing - Internal/External
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SOP writing/review
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Clinical Trials
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Training & Creation of Training Materials
Laboratory Facilities
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Software Implementation (GxP, Annex 11, 21 CFR Part 11)
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Quality Assurance
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Cleanrooms - Human Design
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Novel Cellular Therapies & Translational Research
Collection Centers
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External Audits for Biotech Companies
About
Deborah Griffin
Connect with Deborah
Deborah assists people and companies who struggle with meeting regulatory and accreditation compliance by reviewing their activities and helping them improve their processes.
For the last 27 years, she has been involved in almost every aspect of Cellular Therapy outside of nursing and physician care. Deborah has inspected collection centers, processed all kinds of (human) cells, and documented every activity including interactions with the US FDA and Health Canada.
Her biggest achievement, to date, was co-founding the Early Stage Professional Committee in the International Society for Cell and Gene Therapy - ensuring that future generations have a network and resources to support them in their career path.
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