About Jim Colyn & Associates Quality Consultants, LLC
Jim Colyn & Associates Quality Consultants (JC&A) was founded in 2006 by Jim Colyn, following a career in quality that included 7 years as Director of Quality and Compliance for one of the nation's largest tissue processor and medical device companies.
Today, JC&A offers a wide range of reasonably priced services involving quality system consulting, auditing and training that specifically target compliance and performance for HCT/P organizations, including Human Tissue Processors, Tissue Recovery Organizations, Organ Procurement Organizations, Eye Banks, Reproductive Banks, and Medical Device Manufacturers.
Consulting
Our consulting expertise involves:
- Assistance with the development of quality management systems (cGTP, QSR, ISO)
- Quality system documentation (quality manuals, SOPs and specifications),
- Corrective and Preventative Action Systems,
- Validation planning,
- 483 and warning letter remediation, and
- Joint commission compliance
Auditing
By utilizing our experienced auditors and dedicated comprehensive audit checklists, we can provide your organization a way to save time, money, and resources. Audit Checklists include:
- Tissue recovery banks
- Tissue processors
- Infectious disease testing laboratories
- Analytical laboratories
- Non-clinical GLP laboratories
- ISO 9001 and 13485 organizations
Our audit services ensure that you will not only meet your compliance needs but will help your organizational goals of continual improvement.
Training
We provide the highest quality technical training on a whole range of quality and regulatory related issues to aid in the professional development of your quality and regulatory management staff. We are available for customized on-site training, as well as our pre-scheduled 2-3-day events that cover quality/regulatory, management and human resources topics, all presented from the HCT/P prospective. Our course instructors are the most qualified in the industry, equipping your staff with cutting-edge body of knowledge and practical tools for effective implementation.