Quality Score and Training Methods
(Fairfield, Ohio) – Compliance Insight Inc., a regulatory and quality assurance consulting firm, profiles a proven track record in successfully helping clients who are faced with challenging regulatory and quality assurance situations.
Training: ISO to Q7A
The client, a medium size chemical supply company, needed training. They supplied chemicals to numerous pharmaceutical facilities. Their global corporation wanted to be able to market material as API (active pharmaceutical ingredient), but the client was only currently meeting ISO standards. They needed site-wide knowledge to close the gap between their current ISO system and the requirements of the internationally-
Compliance Insight put together a one-day training session covering the Q7A Guidelines that we could repeat on-site for this client. The goal was for all of their employees to be knowledgeable in Q7A within a short period of time. The training consisted of discussion of how Q7A applied to this facility as well as what they had in place and how they could fill the gaps that existed with the small amount of resources that had been allocated for the project. The organization broke the Q7A guideline up into five units and incorporated hands-on exercises into most of the modules for greater understanding of the material.
The client continues to close their gaps through internal training and auditing programs and is making progress toward completing their Q7A implementation plan.
2011: Major Health Care Product Contract Manufacturer in Mid-West
Temporary QA Department for a Cosmetic and Consumer Products company.
Actively worked on investigations (a) internal-(Deviations, Un-Planned incidents) and (b) external (Customer Complaints).
Internal Audits: all areas of operations of the plan (manufacturing, packaging, warehousing)
CAPAs: followed up on corrective and preventative actions to ensure completion including effectiveness checks.
Compliance Insight Inc. executed changes to increase the company's Quality Score by 40%, saving the company from catastrophic financial downfall and loss of a major client.
Compliance Insight, Inc. specializes in Regulatory and Quality Assurance consulting and training for pharmaceutical, nutraceutical, medical device, chemical, and bio-technology companies in North America, Europe and Asia.
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