Our trained consultants will guide your organization through the implementation of your own quality program, maintenance of your existing program or help analyze the gaps of its effectiveness. We have extensive background in Quality and Regulatory compliance with Current Good Tissue Practice (cGTP) regulations—21 CFR 1270/1271, Quality System Regulations (QSRs) - 21 CFR 820, as the international Quality System Standards—ISO 9001 and ISO 13485. Working in both FDA and non-FDA regulated industries; we have led in the successful ISO registration of six (6) separate facilities.
Quality audits are an integral part of compliance to regulatory requirements. The FDA requires quality auditing to be performed as part of its Quality System Regulation (QSR). Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined target levels to provide evidence concerning reduction and elimination of problem areas. For the benefit of the organization, quality auditing should not only report non-conformances and corrective actions, but also highlight areas of good practice.
Quality organizations and individuals know that they must have the right kind of training to help their staff succeed in a rigorously regulated industry where expectations are for constant improvement. The question is where to go for it. JC&A is meeting the needs of our industry, by providing training on a wide variety of vital skills presented from the HCT/P prospective. Our students go back to their positions with specific knowledge relating to quality systems, quality management and human resources.
Jim Colyn & Associates Quality Consultants, LLC
46 Bingham Lane.
Crossville, TN 38558