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Unlike many other regulatory agencies (which often have the power to pull products from the market only after carrying out their own studies), the FDA acts as a gatekeeper for products in industries that it regulates. The burden of proof is on the product developer, which must show that its product is pure, safe, and effective in order to bring that product to market. FDA applies strict standards in order to ensure that any data supporting product licensure are reliable and reproducible.  FDA’s standards cover not only scientific practices, but also the methods used for documenting results, investigating failures, qualifying personnel, and many other operational functions.  In order to have its data pass muster with FDA, the product developer or testing laboratory must have in place Quality Systems that meet FDA’s standards. Hellerstein Consulting will design, create, and implement these systems for your growing organization.


Quality System development

Key to regulatory compliance, and also to optimal product and data quality, is an independent Quality Assurance unit. Even in organizations with excellent Quality Control, it is critical to have someone to “check the checkers.” We provide contract Quality Assurance services to our clients. We perform document reviews, paper audits, and on-site “friendly” audits. We carry out investigations, conduct training, and perform assessments. Our contract Quality Assurance services are a very cost-effective solution for organizations that have the need for Quality Assurance but do not need a full-time QA professional on staff.  Furthermore, our status as an independent organization satisfies the regulatory agencies’ requirement that Quality Assurance report independently to top management. In a small organization where everyone wears multiple hats, it can be difficult to find anyone who can carry out QA functions without a conflict of interest.  We solve that problem for you.


Contract Quality Assurance

The philosophy of Quality is constantly evolving. Before the 1950s, Quality was generally defined as the absence of defects in a finished product as determined by final inspection. In the second part of the 20th century, guided by revolutionary thinkers like Joseph Juran and W. Edwards Deming, industry adopted a much more holistic view of Quality. Success in the modern economy requires a systematic adoption of Quality policies throughout the product or service life cycle, from initial design through marketing. FDA’s approach to modern Quality began with the Quality System Regulation, 21 CFR 820, which codified the Quality by Design approach for medical devices.  More recently, FDA issued guidances on application of the Quality Systems approach to pharmaceutical development. Hellerstein Consulting can help your organization with its strategy for success through early and effective implementation of Quality policies.


Quality strategy services

OUR CORE SERVICES

In addition to our core services, we offer a variety of other consulting services in the areas of lab startup, biotech operations, outsourcing, process development, Quality Control, science/research (focused on biologics development), and general strategy for problem solving.


Other services

Hellerstein Consulting:  Additional Services Hellerstein Consulting:  QS Development

Unlike many other regulatory agencies (which often have the power to pull products from the market only after carrying out their own studies), the FDA acts as a gatekeeper for products in industries that it regulates. The burden of proof is on the product developer, which must show that its product is pure, safe, and effective in order to bring that product to market. FDA applies strict standards in order to ensure that any data supporting product licensure are reliable and reproducible.  FDA’s standards cover not only scientific practices, but also the methods used for documenting results, investigating failures, qualifying personnel, and many other operational functions.  In order to have its data pass muster with FDA, the product developer or testing laboratory must have in place Quality Systems that meet FDA’s standards. Hellerstein Consulting will design, create, and implement these systems for your growing organization.



Quality System development

Hellerstein Consulting:  Contract QA

Key to regulatory compliance, and also to optimal product and data quality, is an independent Quality Assurance unit. Even in organizations with excellent Quality Control, it is critical to have someone to “check the checkers.” We provide contract Quality Assurance services to our clients. We perform document reviews, paper audits, and on-site “friendly” audits. We carry out investigations, conduct training, and perform assessments. Our contract Quality Assurance services are a very cost-effective solution for organizations that have the need for Quality Assurance but do not need a full-time QA professional on staff.  Furthermore, our status as an independent organization satisfies the regulatory agencies’ requirement that Quality Assurance report independently to top management. In a small organization where everyone wears multiple hats, it can be difficult to find anyone who can carry out QA functions without a conflict of interest.  We solve that problem for you.


Contract Quality Assurance

The philosophy of Quality is constantly evolving. Before the 1950s, Quality was generally defined as the absence of defects in a finished product as determined by final inspection. In the second part of the 20th century, guided by revolutionary thinkers like Joseph Juran and W. Edwards Deming, industry adopted a much more holistic view of Quality. Success in the modern economy requires a systematic adoption of Quality policies throughout the product or service life cycle, from initial design through marketing. FDA’s approach to modern Quality began with the Quality System Regulation, 21 CFR 820, which codified the Quality by Design approach for medical devices.  More recently, FDA issued guidances on application of the Quality Systems approach to pharmaceutical development. Hellerstein Consulting can help your organization with its strategy for success through early and effective implementation of Quality policies.


Quality strategy services

OUR CORE SERVICES

Hellerstein Consulting:  Strategy

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