Change Control
Companies working in a regulated environment need to ensure that changes to a product or system are introduced in a controlled and coordinated manner. Change control is a crucial component to a Quality Management System and reduces the undesirable effects of changes.
Our risk-based change control solutions help ensure cost-effective utilization of resources and ensure that your organization is compliant, effective and efficient.
KEY BENEFITS
Our change control solutions provide insight into:
- The risks and benefits of making/not making product changes.
- How to plan and implement a change control program.
- How to involve key stakeholders.
- Critical change control tools and techniques.
PathWise focuses on a solution-based approach to solving client issues. When training is the appropriate solution, we help simplify the necessary concepts and processes, ensuring a quality system program that conforms to industry and regulatory standards. Our instructors utilize a how-to approach to learning, using a blended application of classroom exercise and real-life experience.
Whether it is remediation resulting from regulatory findings, (Form 483 or Warning Letter) or the objective is to improve quality and compliance before that happens, PathWise will work with your organization to deliver solutions. Our consultants go beyond prescriptive suggestions- we work in tandem with clients to create new systems or write new procedures.
FREE DOWNLOAD
Learn how to manage product change using our Change Control Process Map.
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Why do you need Change Control?
Change Control Management covers the controlled implementation of changes to GMP- related processes, systems and documents to ensure that they are appropriately documented, reviewed, approved, and implemented. This quality standard applies to all changes that can impact safety, quality, identity, purity, potency and strength (SQIPPS) of company products for commercial distribution and clinical trials intended for human use.
Through training in PathWise Project Success managers learned a process for the selection and approval of projects. Team leaders and team members acquired the skills to accomplish projects on time and within scope.
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