Lean Enterprise Six Sigma Training & Consulting
Transforming your Lean and Six Sigma knowledge and initiatives into skill mastery – and results – is most effective when your people receive hands-on support and advice from hands-on experts in the field. Some of the benefits are:
- Projects are completed faster and with more consistent results.
- Participants gain important insights on real world situations that assist them in achieving bigger process improvement.
- Cross-functional support and participation is enhanced, leading to easier implementation and sustained results.
- Opportunities for follow-on projects are more readily identified.
- Business leaders and project Champions can receive guidance on their roles in sponsoring change efforts.
- Your “improvement leaders” get insight into the progress and challenges of specific projects (a written summary is a standard part of our on-site or remote coaching) as well as alerts to issues affecting your overall initiative.
Regulatory & Compliance Support
We offer comprehensive to-market regulatory and evidence development strategies, anticipating areas of regulatory risk and monitoring developments in a continuously changing environment. We handle every facet of regulatory approval, from ISO to a FDA/EMA submissions, documentation and compliance.
Quality System Support
With a solid experience in the life sciences industry, our team of experts can support your quality management activities from a multidimensional perspective; covering more than just the verification that a finished product meets certain expectations. As a component of regulatory standards, quality management requires a system for controlling, monitoring, and verifying any activity or process that could affect product conformance. From the manufacturing floor to the chairman’s office, we need to reiterate the importance of having full global alignment with a culture of quality.
Project & Management Construction
The primary objective of our excellent team of Project Managers is to help our customers achieve all their project goals within the given constraints, risks, resources and another critical success factors in the project life cycle using the best practices.
Clean Room Design / Support
Built upon a solid engineering-knowledge base and focused on our client’s needs, LEC assist clients in preventing and efficiently addressing concerns that arise in their controlled environments. Some of our services are: Filter Selection, Technical support, SOP and Protocol documentation and monitoring, Airflow smoke studies, Calibration services, Validation services and Component / HVAC system validation.
Our team of Subject Matter Experts (SME) offer support in the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and production maintains the desired level of compliance at all stages. In the pharmaceutical industry, in addition to final testing and compliance of products, it is very important to assure that the process will consistently produce the expected results.
Computer Systems Validation
Calibration and Metrology Services & Consulting
¿What are customer are saying?Don't just take it from us, let our customers do the talking!
Dr. Thomas Agrait has provided his consulting services with a great deal of success. He integrated his wealth of knowledge into our processes and systems with extraordinary financial results. He is an excellent leader that lead our teams in completing a plethora of projects on time. Dr. Agrait is a self-directed leader that learns the necessary business processes and provides prompt updates to the leadership team. It is a pleasure working with Dr. Agrait and we look forward to a long term relationship.Manny Arce
Don't Be Shy
If we didn’t answer all of your questions, feel free to drop us a line anytime.