Focus Compliance & Validation Services2018-08-02T21:30:57+00:00
Welcome to Focus Compliance & Validation Services
Core Regulatory Compliance & Validation Services
Focus Compliance & Validation Services provides consulting services to assist our clients in achieving and maintaining FDA regulatory compliance. Our core areas of expertise include: computer system validation; quality system development, implementation, maintenance, and auditing; response to agency actions including 483s and warning letters; FDA mock inspections and mock recalls; training; risk management; process validation and equipment qualification; and related assistance. We have experience providing these services in the medical device, pharmaceutical, and biotech industries.
Computer Systems Validation
Medical Device Industry
Pharmaceutical Industry
Regulatory Affairs/GXP Compliance
Blood and Plasma Industry
Pharmaceutical Packaging Industry
Focus Compliance & Validation Services is located at 4700 Papermill Drive in Knoxville, Tennessee.

Webinar – Newly Released Data Behind FDA’s Historic Clearance of IDx-DR – Wednesday, August 29, 2018 from 12:00 pm to 12:30 pm CDT

The technology known as CRISPR — clustered regularly interspaced short palindromic repeats — has taken the field of synthetic bioengineering by storm. It emerged as a gene-editing tool only five years ago, but has become a familiar presence in the lab.

The benefits of synthetic bioengineering with CRISPR

CRISPR-Cas9, the full name for the editing system that uses the Cas9 enzyme as molecular scissors, cuts DNA at any desired location. CRISPR’s versatility makes it a popular tool for current and future research projects. Engineers and scientists are using CRISPR to modify and repair DNA in single organisms, create cell and animal models to help accelerate disease and clinical research, and develop CRISPR-based gene drives that can disrupt the spread of animal-borne diseases.

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Application of Agile of Medical Device Systems – September 19-21, 2018 in Arlington, VA

For many years software development teams have been using Agile Software Development methods, but Agile is not just for software. Agile’s Lean Product Development principles also apply to the development of hardware-based products and systems. This two and a half day course goes beyond small-team and software-only applications and demonstrates how Agile practices can be used in the development of medical device systems.

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Design Control – Integrating The Quality System Regulation and ANSI/AAMI/ISO 13485 Requirements – September 5-7, 2018 in Freising, Germany

This intensive 2½ day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. This course offers FDA and industry the unique opportunity to participate in a shared learning experience. Examples of design control tools, templates, and practices, in use by AAMI member companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program. The content focuses on the how-to’s of implementing a program that meets FDA’s design control requirements while ensuring a fast and efficient flow of new products.

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