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

Webcast – Health Canada and FDA Joint Public Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – April 3, 2020, 10 am to 1 pm ET

This meeting will now be held via webcast only.

The Food and Drug Administration (FDA) is announcing a regional public meeting entitled ‘‘Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonization of Technical Requirements for Human Use (ICH)’’ to provide information and receive comments on the current activities of ICH as well as the upcoming meetings in Vancouver, Canada, in May 2020. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting. The purpose of the public meeting is to solicit public input prior to the next ICH Assembly meeting and the expert working groups meetings in Vancouver, Canada, scheduled for May 23 through 27, 2020, at which the discussion of the topics underway will continue.

For more info and webcast access:  https://www.fda.gov/drugs/news-events-human-drugs/health-canada-and-fda-joint-public-consultation-international-council-harmonisation-technical-0

TN Chamber: How to Stay Productive While Working Remotely, FREE Webinar – Tuesday, March 24, 2020 at 11 am EDT

Is your business being tasked with the challenge of continuing to conduct business while ensuring the safety of all employees? In light of recent events, many businesses are implementing work-from-home policies to help meet both objectives.

Join ICG on Tuesday, March 24, 2020, at 11:00 AM EDT for our webinar, “Sustaining Business Operations in an Age of Uncertainty”, where we will discuss the options, timelines and best practices needed to safely implement a work-from-home policy including:

·     Planning, setting and managing goals for your workforce

·     Maintaining a high level of IT security as you move the security boundaries outside your corporate walls

·     Maintaining a higher level of communication and the tools that make this effective

·     Biggest Challenge—How to access your legacy, productivity applications, and data remotely

·     “Keeping the lights on” in your datacenter

·     Help Desk—How to manage devices remotely and keep your workforce productive

·     Culture Change: Best practices and avoiding common mistakes people make when working from home

REGISTER NOW:  http://info.icgtechnology.com/en/en/webinar-sustaining-business-operations-in-an-age-of-uncertainty-0?utm_campaign=Webinar%3A%20Sustaining%20Business%20Operations%20During%20an%20Age%20of%20Uncertainty&utm_medium=email&_hsenc=p2ANqtz-9EknwJnc9LGAMcMpHTpDnMTWLA_eByHTXnc-C_lHdiJcT24aHc6XghdxzSmr0TpP2UfvQTy9deU08Il76mGkmVsv2Vyv9JitgZeGvMEcMQeuhREJw&_hsmi=2&utm_source=hs_email&utm_content=2&hsCtaTracking=77c86acd-3d96-45e6-bbb3-42b7f567bfdd%7Ccfb4f98b-e1a2-423c-b0ee-5bb5cc084111

Can’t attend the session live, but still want to learn? No worries. Share the link with your colleagues and register anyways—we will send you a live recording after the webinar to save forever!

Coronavirus Guidelines for America

THE PRESIDENT’S CORONAVIRUS GUIDELINES FOR AMERICA

Listen to and follow the directions of your STATE AND LOCAL AUTHORITIES.

IF YOU FEEL SICK, stay home.  Do not go to work.  Contact your medical provider.

IF YOUR CHILDREN ARE SICK, keep them at home.  Do not send them to school.  Contact your
medical provider.

IF SOMEONE IN YOUR HOUSEHOLD HAS TESTED POSITIVE for the coronavirus, keep the entire household at
home.  Do not go to work.  Do not go to school.  Contact your medical provider.

IF YOU ARE AN OLDER PERSON, stay home and away from other people.

IF YOU ARE A PERSON WITH A SERIOUS UNDERLYING HEALTH CONDITION that can put you at increased risk
(for example, a condition that impairs your lung or heart function or weakens your immune system),
stay home and away from other people.

For more info:  https://www.whitehouse.gov/briefings-statements/coronavirus-guidelines-america/