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.

Regulatory Requirements for Software Validation – March 19-21, 2018 in Arlington, VA

This 3-day course focuses on the requirements contained in the Quality System regulation specific to software validation. The course explores the latitude and flexibility of the FDA’s expectations and provides conceptual ways to meet compliance requirements. Relevant standards, FDA guidance documents, and other resources will be discussed that assist in determining compliance practices.

For more info:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=5627


Webinar: Writing Human Factors Plans and Reports – March 15, 2018

As a medical technology developer who seeks to apply human factors engineering (HFE) effectively to produce safe and effective devices and to satisfy regulators’ requirements and expectations, you may be frustrated that pre-existing guidance only describes how to perform specific HFE techniques but does not provide sample work products (e.g., test plans, test reports).

A new webinar from AAMI, in conjunction with the release of Writing Human Factors Plans and Reports for Medical Technology Development, has been developed to fill a perceived gap in the guidance available to medical technology developers like you.

The webinar and publication provide sample work products and supplemental job aids that offer document preparation advice and have been peer-reviewed by a panel of HFE experts.

For more info:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=5711

Integrating Risk Management into the Quality System Course – March 12-14, 2018 in Arlington, VA

This comprehensive 2.5 day course for medical device manufacturers presents risk management concepts used throughout the quality system as well as the life cycle of the product, from design…to manufacturing…through post-production.

For more information:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=5626