Focus Compliance & Validation Services2018-08-02T21:30:57+00:00
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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.
OUR SERVICES
Computer Systems Validation
Medical Device Industry
Pharmaceutical Industry
Regulatory Affairs/GXP Compliance
Blood and Plasma Industry
Pharmaceutical Packaging Industry
CONTACT FOCUS CVS
OUR LOCATION
Focus Compliance & Validation Services is located at 4700 Papermill Drive in Knoxville, Tennessee.
NEWS AND EVENTS

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – February 4-8, 2019 in Arlington, VA

This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems.

For more info and to register:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=7179

Lunar Eclipse 2019: How to watch the “super blood wolf moon” – overnight January 20-21, 2019

Skywatchers across the continental U.S. will be treated to a total lunar eclipse overnight on Jan. 20-21, when Earth’s shadow sweeps over the lunar surface to give it a reddish tinge and turn it into what some call a “blood moon.”

This will be the first lunar eclipse of 2019 and the last total lunar eclipse until 2021. It coincides with the year’s first full moon — a “wolf moon” in the folklore tradition because it occurs at a time of year when wolves howl outside villages — and comes when the moon is slightly bigger and brighter because it’s at the closest point to Earth in its elliptical orbit.

Since it’s a so-called supermoon that’s being shadowed, some media outlets have dubbed this eclipse a “super blood wolf moon.”

For more info:  https://www.nbcnews.com/mach/science/lunar-eclipse-2019-how-watch-super-blood-wolf-moon-ncna954941

9th ICBE – International Conference on Biomolecular Engineering – January 6-9, 2019 in Newport Beach, CA

ICBE brings together researchers who are using quantitative approaches to advance the understanding and application of molecular biology. The upcoming conference will be in beautiful Newport Beach, CA. Academic, clinical, and industrial researchers are invited to share their recent discoveries to progress the field in biomolecular science and engineering.

For more info:  https://www.aiche.org/sbe/conferences/international-conference-biomolecular-engineering-icbe/2019