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

Emergency Use Authorizations for the Decontamination of N95 Respirators – Webinar Recording Available Now

The U.S. Food and Drug Administration has issued emergency use authorizations for select sterilization systems that will allow N95 or N95-equivalent respirators to be decontaminated. The sterilization systems will help address the shortage of these vital masks used by healthcare workers to protect themselves from exposure to the novel coronavirus.

 

This May 4 webinar featured an expert from 3M who addresses the 3M perspective on the decontamination of N95 respirators and shares important caveats about doing so, as well as representatives from STERIS, Battelle, Advanced Sterilization Products (ASP), and Sterilucent, each of whom have systems covered by EUAs. Following the expert presentations, is a Q&A session.

 

Systems covered under EUA that will be addressed include:

  • STERIS: STERIS V-PRO 1 Plus, maX, and maX2 (Low Temperature Sterilization Systems)
  • Battelle: Battelle CCDS Critical Care (Decontamination System)
  • ASP: STERRAD 100S, NX, and 100NX (Sterilization Systems)

Sterilucent: Sterilucent HC 80TT Hydrogen (Peroxide Sterilizer)

For recording:  https://www.aami.org/news-resources/covid-19-updates/covid-19-town-halls-and-webinars?_zs=REXf81&_zl=URxk5

Essential News for Tennessee’s Economic Recovery – Governor Lee’s Executive Orders to Reopen the Economy

Governor Lee issued Executive Order 29 on Friday, to allow restaurants to reopen at limited capacity. The order created questions as some local governments considered issuing their own reopening plans and what that would mean in conjunction with Governor’s Lee Tennessee Pledge. Today, Attorney General Herbert Slatery issued a legal opinion on Governor Lee’s executive orders, and if they may supersede local orders. The Tennessee Chamber has closely the situation to ensure that businesses get clear and concise updates in regards to reopening.

General Slatery’s opinion is beneficial for businesses to know which political subdivision to abide by and eliminates the possibility of a myriad of rules that would be problematic to business’s opening successfully. The governor’s emergency powers trump the authority of local health departments to issue restrictions in response to the coronavirus pandemic, according to a rare legal opinion issued by state Attorney General Herbert Slatery. Governor Bill Lee, who has launched a re-opening of some businesses in recent executive orders, then decreed that restaurants across the state, could reopen today for dine-in under strict health conditions. He said the re-opening in large cities was subject to the approval of the County Health Department. The opinion was requested by Senate Speaker Randy McNally (R-Oak Ridge) and House Speaker Cameron Sexton (R-Crossville) It’s just the seventh legal opinion issued by Slatery’s office this year.

For more information and related topics:  https://myemail.constantcontact.com/Daily-Dashboard–Attorney-General-Slatery-Opinion-Brings-Clarity-to-Businesses-Across-State.html?soid=1126878176488&aid=dlS3WTie38E

TN Chamber of Commerce – Healthy Business Certification – Five Course Offerings THIS Week!

The TN Chamber of Commerce is offering Healthy Business Certification online.  Completion of the three hour Tennessee Chamber Healthy Business Certification will be offered online and and is designed for any worker that wants to acquire knowledge on workplace health and pandemic response.

This intensive training will review OSHA regulations, CDC and WHO recommendations for operating during a pandemic.  Training will include the development of a customized Infectious Disease Prevention Control Plan for your facility or business. This plan is crucial to demonstrate and document your efforts to maintain a healthy and disease free workplace.

Courses will be industry specific.

For more information and to register, go to http://www.tnchamber.org – Select Events Calendar. Click on date of webinar.